FDA Adverse Event Malfunction Summary report: N

HL-20 INTEGRATED PERFUSION SYSTEM

MDR report key: 4283250 · Received November 28, 2014

Report

Report Number: 8010762-2014-01078
Event Type: Malfunction
Date Received: November 28, 2014
Date of Event: September 15, 2011
Report Date: September 15, 2011
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DTQ
PMA / PMN Number: K943803
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE HOSPITAL SUBMITTED VOLUNTARY REPORT NO. MW5023485 TO THE FDA REGARDING THE EVENT THAT OCCURRED ON (B)(6) 2011. NOTE:THE SERIAL NUMBER WAS NOT PROVIDED IN VOLUNTARY REPORT. SERVICE ORDER (B)(4) WAS GENERATED FOR THE EVALUATION OF SERIAL NUMBER (B)(4). PER SERVICE ORDER, EXTENSIVE TESTING WAS PERFORMED AND THE ERROR COULD NOT BE REPRODUCED. A PREVENTIVE MAINTENANCE(PM) WAS PERFORMED ON EACH UNIT. SERIAL NUMBERS DEVICE MANUFACTURER DATE APPROXIMATE AGE(B)(4) 04/2005 6.5 YEARS(B)(4) 08/2005 6.1 YEARS(B)(4).

Description of Event or Problem · 1

ON (B)(6) 2011, (B)(6) HOSPITAL REPORTED THAT DURING AN OPEN HEART CASE, THE ARTERIAL PUMP HEAD (SINGLE ROLLER PUMP) SHUT OFF WITH-OUT ANY WARNING. THERE WERE NO ALARMS, ERROR CODES, OR INTERVENTION. THE PUMP WAS REBOOTED AND IT STARTED UP AGAIN. THE CASE WAS FINISHED WITH THE PUMP IN QUESTION. THE CUSTOMER NOTED THAT THIS EVENT OCCURRED ON (B)(6) 2011. ADDITIONALLY, TWO SERIAL NUMBERS ((B)(4)) WERE IDENTIFIED. THEREFORE, TWO MFR REPORT WILL BE SUBMITTED FOR THIS EVENT. REFERENCE MFR REPORT# 8010762-2014-00510 FOR THE SECOND EVENT. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
771274	HL-20 INTEGRATED PERFUSION SYSTEM	CONSOLE, HEART-LUNG MACHINE	DTQ	MAQUET CARDIOPULMONARY AG	70102.8674

Patients

Seq	Age	Sex	Outcome	Treatment
1