FDA Adverse Event Malfunction Summary report: N

HLM TUBING SET W/BIOLINE COATING

MDR report key: 5500206 · Received March 15, 2016

Report

Report Number: 8010762-2016-00176
Event Type: Malfunction
Date Received: March 15, 2016
Date of Event: February 26, 2016
Report Date: February 26, 2016
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DWE
PMA / PMN Number: K101153
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PRODUCT WAS NOT REQUESTED TO RETURN FOR MANUFACTURER'S INVESTIGATION AS THE FAILURE IS KNOWN AND HAS BEEN INVESTIGATED IN A PREVIOUS COMPLAINT. THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION BY THE PREVIOUS COMPLAINT INVESTIGATION. BASED ON THESE RESULTS AND THE INFORMATION AVAILABLE AT THIS TIME, THE OXYGENATOR OPERATED WITHIN MAQUET CARDIOPULMONARY SPECIFICATIONS. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510(K): K101153.

Description of Event or Problem · 1

(B)(4). ACCORDING TO THE CUSTOMER: DURING FIRST HOUR OF ECLS (EXTRA CORPORAL LIFE SUPPORT)SUPPORT WITH CARDIOHELP, HLS MODULE DEVELOPED LARGE PRE-MEMBRANE PRESSURE REQUIRING CHANGE OUT (PINT RISING TO 250MMHG). NO NEGATIVE EFFECT TO PATIENT REPORTED. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
156925	HLM TUBING SET W/BIOLINE COATING	TUBING, PUMP, CARDIOPULMONARY BYPASS	DWE	MAQUET CARDIOPULMONARY AG	BEQ-HLS 7050 USA

Patients

Seq	Age	Sex	Outcome	Treatment
1