FDA Adverse Event Malfunction Summary report: N

BE-PLS 2050 PERMENANT LIFE SUPPORT

MDR report key: 3826442 · Received February 28, 2014

Report

Report Number: 8010762-2014-00102
Event Type: Malfunction
Date Received: February 28, 2014
Date of Event: February 15, 2014
Report Date: February 15, 2014
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DTZ
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE IS NOT DISTRIBUTED IN USA BUT SIMILAR DEVICE IS DISTRIBUTED UNDER K112360. MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR INCIDENTS WITH DIFFERENT ROOT/CAUSES. THE PROVIDED INFO IS NOT ENOUGH TO DETERMINE THE ROOT-CAUSE, THE CUSTOMER PROVIDED THE LOT NUMBER OF THE DEVICE AND TRACING THE MFG RECORDS IS NOT POSSIBLE WITHOUT THE SERIAL NUMBER. THE COMPLAINTS STATISTICS SHOWED ONE MORE COMPLAINT WAS RECEIVED FROM THE SAME LOT BUT WITH A DIFFERENT FAILURE. IN ADDITIONAL, THE POSSIBILITY OF THIS ERROR OCCURRING DURING PRIMING (BEFORE PT IS INVOLVED) IS COVERED IN THE OPERATING INSTRUCTIONS. IT IS RECOMMENDED THAT THE DEVICE NOT BE USED IF THIS OCCURS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE OXYGENATOR STARTED LEAKING DURING BLOOD PRIME CIRCULATION. LEAK DURING PUMP RUNNING AT 4.5 LITERS FLOW AND HAD TO REPLACE THE UNIT IMMEDIATELY SINCE IT WAS H1N1 POSITIVE CASE THE DEFECTIVE DEVICE IS DESTROYED. REF: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
124354	BE-PLS 2050 PERMENANT LIFE SUPPORT	DIFFUSION MEMBRANE OXYGENATOR	DTZ	MAQUET CARDIOPULMONARY AG	70102.7818	70085690

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR