FDA Adverse Event Malfunction Summary report: N

MAQUET HL-20 TWIN PUMP

MDR report key: 4280391 · Received November 26, 2014

Report

Report Number: 8010762-2014-01077
Event Type: Malfunction
Date Received: November 26, 2014
Date of Event: August 18, 2011
Report Date: September 2, 2011
Manufacturer: MAQUET CARDIOPULMOARY AG
Product Code: DPW
PMA / PMN Number: K984338
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE FIELD SAFETY ENGINEER (FSE) PERFORMED THE UPDATE MCV/011/0002/IU ON 2 TPMS. THE FSE UPDATED SOFTWARE VERSION 1.4 TO VERSION 2.5. BASED UPON COMMUNICATION WITH THE SERVICE DEPARTMENT, THE VERSION 2.5 SOFTWARE WAS ONLY FOR RELEASE 11 TPMS, THE TPMS INVOLVED IN THIS EVENT WERE RELEASE 10. THE FSE WAS INSTRUCTED TO REINSTALL THE OLD, VERSION 1.4 SOFTWARE ON THE TPMS. REFERENCE: COMPLAINT (B)(4)

Description of Event or Problem · 1

ON (B)(6) 2011, (B)(6), AN "ARTERIAL STOP" ERROR WAS RECEIVED ON TWIN PUMP MODULE (TPM) EN MED C (ARTICLE NUMBER: (B)(4)) WHILE BEING USED WITH HL20 5 PUMP CONSOLE (ARTICLE NUMBER: (B)(4)) THE ARTERIAL PUMP WORKS PROPERLY (E.G. 100 ROTATIONS/MIN), HOWEVER, THE CARDIOPLEGIA PUMP (IN SLAVE MODE) TURNS A QUARTER OF TURN, THEN STOPS, THEN TURNS A HALF A TURN, THEN STOPS, AND SO ON. THIS PROBLEM WAS OBSERVED AFTER THE FIELD SERVICE ENGINEER PERFORMED A SOFTWARE UPDATE ON THE TPM FROM VERSION 1.4 TO NEW SOFTWARE VERSION 2.5. A SECOND MDR WILL BE GENERATED FOR THIS EVENT SINCE TWO TWIN PUMP MODULE AND CONSOLE SERIAL NUMBERS ARE LISTED IN THE COMPLAINT. THE SECOND MDR # IS 8010762-2014-00504. REFERENCE: COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
768272	MAQUET HL-20 TWIN PUMP	FLOWMETER, BLOOD, CARDIOVASCULAR	DPW	MAQUET CARDIOPULMOARY AG	MCP00703277

Patients

Seq	Age	Sex	Outcome	Treatment
1