Wednesday, 19 July 2017 12:16

Field Correction Of Certain Intra-Aortic Ballon Pumps (Iabps)

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The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by the US FDA that Datascope Corp. is voluntarily performing a field correction of certain Intra-Aortic Ballon Pumps (IABPs) due to a potential electrical test failure code. This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.

Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability.

Datascope received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve.

The affected IABP units were distributed worldwide (in over 100 countries). There are approximately 12,000 affected units sold globally.

The details of the affected units are as follows:

AFFECTED PRODUCT

PART NUMBER

CS100i IABP 0998-UC-0446HXX; 0998-UC-0479HXX

CS100 IABP 0998-00-3013-XX;  0998-UC-3013-XX

CS300 IABP

0998-00-3023-XX;  0998-UC-3023-XX

Distribution Dates:     March 23, 2003, and December 11, 2013

Healthcare provider’s action

Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Please adhere to the following instructions when using affected devices:

  • Pursuant to the USER Instruction WARNINGS, clinicians are instructed not to leave the patient unattended during IABP therapy.
  • An additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. It is important to note the following WARNING in the CS100i, CS100 or CS300 IABP Operating Instructions Manual:
  • WARNING: The patient balloon should not remain inactive in the patient (i.e., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.
  • Until the service is performed, Datascope recommends powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.
  • A service representative from Datascope will be replacing the defective solenoid driver boards. Customers having affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service.

Healthcare providers and patients should report adverse events associated with the use of this system to the nearest NAFDAC office, NAFADC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC………..Safeguarding the Health of the Nation!!!

Read 1124 times Last modified on Wednesday, 19 July 2017 12:33

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