FDA Adverse Event Malfunction Summary report: N

TANDEMHEART PUMP

MDR report key: 864183 · Received June 11, 2007

Report

Report Number: 2531527-2007-00004
Event Type: Malfunction
Date Received: June 11, 2007
Date of Event: May 7, 2007
Report Date: June 6, 2007
Manufacturer: CARDIAC ASSIST, INC.
Product Code: KFM
PMA / PMN Number: K991783
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: AN EVALUATION WAS CONDUCTED UPON RECEIPT WHICH CONFIRMED THAT THE PUMP WAS NON-FUNCTIONAL. ANALYSIS OF THE PUMP FOUND EVIDENCE OF DAMAGE CAUSED BY INTERFERENCE BETWEEN THE BEARING PORTIONS OF THE INTERNAL PUMP COMPONENTS WHICH RESULTED IN THE PUMP FAILURE.

Description of Event or Problem · 1

THE CLINICAL STAFF OF THE HOSPITAL CONTACTED CARDIACASSIST TO REPORT, THAT THE ESTIMATED BLOOD PUMP FLOW WAS UNUSUALLY HIGH AND THAT AIR WAS NOTED IN THE INFUSION SYSTEM. CARDIACASSIST PROVIDED FEEDBACK TO CORRECT THE PROBLEM AS WELL AS ADDITIONAL GUIDANCE FOR PROPER SYSTEM OPERATION. AFTER APPROXIMATELY 14 HOURS OF USE, THE PUMP HALTED AND ATTEMPTS TO RESTART IT WAS NOT SUCCESSFUL. THE PATIENT WAS NOT ADVERSELY IMPACTED BY THE INCIDENT. THE TANDEMHEART SYSTEM IS CURRENTLY APPROVED FOR 6 HOUR USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TANDEMHEART PUMP	NON-ROLLER TYPE BYPASS PUMP	KFM	CARDIAC ASSIST, INC.	TANDEMHEART

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Required Intervention