FDA Adverse Event Malfunction Summary report: N

HLM TUBING SET W/BIOLINE COATING

MDR report key: 4774508 · Received May 13, 2015

Report

Report Number: 8010762-2015-00457
Event Type: Malfunction
Date Received: May 13, 2015
Date of Event: April 29, 2015
Report Date: April 29, 2015
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DTZ
PMA / PMN Number: K101153
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS RECEIVED FOR MANUFACTURER'S LABORATORY INVESTIGATION. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE. THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS UNDER 510 (K): K101153.

Description of Event or Problem · 1

ACCORDING TO THE CUSTOMER: "DURING RECIRCULATION AFTER PRIMING (CLOSED LOOP / CIRCUIT, PRIMING CONTENT RINGERLACTAAT AND FOLLOWED THE IFU) THERE WAS AIR SEEN IN THE PUMPHEAD (UPPER INFLOW LEVEL) AND ALSO ON THE ARTERIAL SIDE OF THE OXY. AFTER REATTACHING THE PRIMING BAG AND AGAIN DE-AIRING OF THE SYSTEM THE AIR WAS SEEN AGAIN ON BOTH SIDES. WE DECIDED TO CHANGE OUT THE HLS SET IN TOTAL. NEW SET WAS PRIMED AND THIS WAS OK."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
312273	HLM TUBING SET W/BIOLINE COATING	DTZ (OR DWE)	DTZ	MAQUET CARDIOPULMONARY AG	BE-HLS 7050	70097665

Patients

Seq	Age	Sex	Outcome	Treatment
1