report form field safety corrective action
TRANSCRIPT
new case, keep base data
Report Form Field Safety Corrective Action
Medical Devices Vigilance System (MEDDEV 2.12/1 rev 7)
Version 2.7en 2012-12-03
1 Administrative information
To which NCA(s) is this report being sent?Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)Type of report
Final reportFollow-up reportInitial report
Date of this report
2019-06-19Reference number assigned by the manufacturer
2249723-05/17/2019-001-C---SI
Name of the co-ordinating NCACompetent Authority (if applicable)
BfArM
Incidence reference number assigned by NCA
TBD
FSCA reference number assigned by NCA
TBD
2 Information on submitter of the report
Status of submitter
Authorised Representative within EEA and SwitzerlandManufacturer
Others: (identify the role)
3 Manufacturer information
Postcode
07430
Contact Name
Marylou Insinga -Regulatory Contact
Address
1300 MacArthur Blvd.
Name
Datascope Corp. Getinge
City
MahwahFax
1-973-807-9290
Phone
+1 973 709 7442Country
US - USA
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4 Authorised Representative Information
Postcode
DE-76227
Contact Name
Arne BriestAddress
Kastellstr. 8
Name
VISAMED GmbH
City
KarlsruheFax
+49 721 476 4849
Phone
+49 170 488 8498Country
DE - Germany
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5 National contact point information
Postcode
34734
Name of the contact person
Dicle Ergin Öztürk
Address
Kozyatagi Mh. Sari Kanarya Sk. No:14 K:4 Kadıkoy
National contact point name
Getinge Tibbi Sistemler San. Ve Tic. A.S.
City
IstanbulFaxPhone
+90 216 444 66 78Country
TR - Turkey
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6 Medical device information
Nomenclature code
36340
Nomenclature text
Circulatory assist system, intra-aortic balloon
Nomenclature system (preferable GMDN)
GMDN
Commercial name/ brand name / make
Cardiosave, CS100,CS300 Intra-Aortic Balloon Pumps
Model number
0998-00-0800-XX, 0998-UC-0800-XX, 0998-00-3013-XX,
Catalogue number
N/A
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MDD Class I
MDD Class IIbMDD Class III
MDD Class IIa IVD Devices for self-testing
IVD Annex II List AIVD Annex II List B
IVD General
AIMD Active implants
Class
Serial number(s)
All Cardiosave serial numbers distributed March 6, 2012 to present All CS100 and CS300 serial numbers distributed March 24, 2003 to present
Lot/batch number(s)
N/A
Device Mfr Date
Notified Body (NB) ID-number
2797
Expiry date
Accessories / associated devices (if applicable)
N/A
Software version number (if applicable)
N/A
7 Description of the FSCA
Background information and reason for the FSCA
Getinge consistently tracks reported events and complaints in relation to the subject battery information; however, the actions included in this Field Correction will further strengthen the guidance outlined in the Health Care Provider letter posted by the FDA on their website, November, 1st 2018, Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers. (Reference: https://www.fda.gov/medical-devices/letters-health-care-providers/device-failure-associatedgetinges- maquetdatascope-intra-aortic-balloon-pumps-letter-health-care) There have been five patient deaths reported since March 2016, although the deaths cannot be definitively attributed to the device shutting down while operating on battery power.Description and justification of the action (corrective / preventive)
This field correction is being conducted to ensure that all IABP users follow each device's Operating Instructions Manual for recommendations on usage, charging, maintenance and storage of the batteries. A FSN will be sent to affected customers in regards to this field correction.
Advice on actions to be taken by the distributor and the user
Read and follow the instructions in the FSN Initial Action - Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP and CS100 IABP: • Getinge has developed a battery operations, care and maintenance reference guide specific to the IABP(s) based on the Operating Instructions Manual(s) provided with each device. These guides are available by accessing the link provided below: info.getinge.com/ca-batteryguides A hard copy of the guides are available upon request by contacting your local Sales and Service Representative. Additional Actions - Cardiosave Hybrid IABP, Cardiosave Rescue IABP: • Getinge is currently developing a Cardiosave battery maintenance software upgrade targeted for early 2020. This updated software requires FDA clearance and once completed, a Getinge Service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. • NOTE: A similar software upgrade was released for the CS300 IABP and CS100 IABP in 2017. If you are unsure whether your IABP has been updated with the released software upgrade, please contact your Getinge Sales & Service Office with the Model and Serial number of the IABP. The Sales & Service Office will determine if the IABP software has been updated.Progress of FSCA , together with reconciliation data (Mandatory for a Final FSCA)
The FSCA is currently being initiated.
Time schedule for the implementation of the different actions
All affected customers will be notified of the FSCA as soon as possible. The expected time frame for completion of the FSCA is December 2020.
Attached please find
Field Safety Notice (FSN) in English Draft FSN
Final FSNOthers (please specify)
FSN in national language
FSN Status
within the EEA and Switzerland
Candidate Countries
The medical device has been distributed to the following countries:
AT BE BG CH CY CZ DE DKEE ES FI FR GB GR HU IEIS IT LI LT LU LV MT NLNO PL PT RO SE SI SK
HR
TR
All EEA, candidate countries and Switzerland
Others:
AE,AF,AR,AU,AZ,BA,BD,BH,BN,BO,BR,BY,CA,CL,CN,CO,CR,DO,DZ,EC,EG,GE,GH,GT,GY,HK,HN,ID,IL,IN,IQ,IR,JO,JP,KE,KH,KP,KR,KW,KZ,
8 Comments
Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorised representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
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I affirm that the information given above is correct to the best of my knowledge
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