FDA Adverse Event Injury Summary report: N

OXYGENATOR, CARDIOPULMONARY BYPASS

MDR report key: 4736210 · Received April 27, 2015

Report

Report Number: 8010762-2015-00402
Event Type: Injury
Date Received: April 27, 2015
Date of Event: March 26, 2015
Report Date: April 10, 2015
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DTZ
PMA / PMN Number: K102464
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. BASED ON THIS A CONFIRMATION OF THE FAILURE BY MANUFACTURER'S LABORATORY INVESTIGATION IS NOT POSSIBLE. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY 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 UNDER SECTION D IS A SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I NEONATAL WHICH IS REGISTERED UNDER 510 (K): K102464.

Description of Event or Problem · 1

ACCORDING TO CUSTOMER'S INFO: "BAD GAS EXCHANGE PERFORMANCES:. (B)(6); ARTERIAL BLOOD FLOW: 990 ML/MIN. THE PRODUCT WAS NOT REPLACED DURING TREATMENT. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
276739	OXYGENATOR, CARDIOPULMONARY BYPASS		DTZ	MAQUET CARDIOPULMONARY AG	VKMO 11000	92125747

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other