FDA Adverse Event Malfunction Summary report: N

DESCRIPTION FROM THE CUSTOMER REPORT:

MDR report key: 5888727 · Received August 19, 2016

Report

Report Number: 8010762-2016-00527
Event Type: Malfunction
Date Received: August 19, 2016
Date of Event: August 1, 2016
Report Date: August 3, 2016
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DTZ
PMA / PMN Number: K082117
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET (B)(4). THE PRODUCT WAS NOT REQUESTED FOR RETURN TO THE MANUFACTURES LABORATORY FOR INVESTIGATION AS THE FAILURE IS KNOWN AND WAS THOROUGHLY INVESTIGATED UNDER CAPA (B)(4). THE INVESTIGATION UNDER CAPA (B)(4) IDENTIFIED THAT THE FAILURE IS CAUSED BY TOLERANCE INTERFERENCES IN CURRENT DESIGN. MAQUET CARDIOPULMONARY WILL IMPLEMENT CORRESPONDING ACTION STEPS REGARDING THE DESIGN AND TOLERANCE CRITERIAS OF THE DIALYSIS PORT. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THIS COMPLAINT WILL BE CLOSED. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

Description of Event or Problem · 1

(B)(4).

Description of Event or Problem · 1

DESCRIPTION FROM THE CUSTOMER REPORT: "CUSTOMER STATED THAT THE BLOOD WAS OOZING FROM DIA-CONNECTOR LOCK AND VALVE WHEN SURGERY IN PROGRESS. PRODUCT WAS NOT REPLACED AND NO DELAY IN TREATMENT." (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
542207	DESCRIPTION FROM THE CUSTOMER REPORT:	OXYGENATOR, CARDIOPULMONARY BYPASS	DTZ	MAQUET CARDIOPULMONARY AG	VKMO 71000	92198337

Patients

Seq	Age	Sex	Outcome	Treatment
1