Field Correction for Datascope Intra-aortic Balloon Pumps

Megan Brooks

June 21, 2017

SILVER SPRING, MD — Datascope Corp/Maquet has initiated a worldwide "field correction" of certain intra-aortic balloon pump (IABP) systems to address potential electrical test failures, a MedWatch alert from the US Food and Drug Administration notes[1].

The company will do a voluntary onsite field correction of the affected products, the FDA statement notes. The correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP, according to a company press release.

Datascope said it received a complaint about a patient death due to the failure of a CS300 IABP to initiate therapy. The IABP did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure, the company said.

Failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve, they note. A service representative from Datascope will be replacing the defective solenoid driver boards.

Affected Datascope Products

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

Roughly 12,000 affected IABP units were distributed in the US and more than 100 other countries between March 23, 2003 and December 11, 2013. Units distributed after December 11, 2013, are not affected by the field correction.

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

When using affected devices, patients should not be left unattended and the balloon should not be left inactive in the patient (that is, not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation, the company said.

Until the field correction is performed, the company recommends powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test, which should take less than 60 seconds. If the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, the IABP should be removed from service and the local Maquet/Getinge sales and service office contacted.

Customers with affected IABP units will be contacted by a representative of the Maquet/Getinge service team to schedule on-site service. For additional information regarding this field correction, please contact the customer service department at 1-888-627-8383 and press 2 (Monday through Friday from 8:00 AM to 6:00 PM EDT).

To report any problems with these products, contact MedWatch, the FDA's safety information and adverse-event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online; with postage-paid FDA form 3500, available online; or by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

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