FDA Adverse Event Malfunction Summary report: N

UNIV OF VA CHARLOTTESVILLE VA1

MDR report key: 2087266 · Received April 15, 2011

Report

Report Number: 1718850-2011-00027
Event Type: Malfunction
Date Received: April 15, 2011
Date of Event: March 18, 2011
Report Date: March 18, 2011
Manufacturer: SORIN GROUP USA, INC.
Product Code: DWE
PMA / PMN Number: PREAMENDMENT
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A F/U REPORT WILL BE FILED IF THIS INFO IS RECEIVED. SORIN GROUP (B)(6) MANUFACTURES THE PRIMO2X OXYGENATOR AND THE 510(K) NUMBER IS K050447. THE OXYGENATOR IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE INCIDENT OCCURRED AT THE (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(6). THE PRIMO2X OXYGENATOR WAS RETURNED TO SORIN GROUP USA WITH A REPORT THAT BLOODY WATER WAS SEEN COMING OUT OF THE HEAT EXCHANGER AT THE END OF A CASE. A VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS. TESTING OF THE DEVICE DID IDENTIFY A LEAK PATH BETWEEN THE BLOOD SIDE AND WATER SIDE OF THE HEAT EXCHANGER. THE OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(6) FOR FURTHER EVAL. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

THE PERFUSIONIST REPORTED THAT AT THE END OF THE CASE, THE HEAT EXCHANGER WATER LINES WHICH HAD BEEN CLAMPED DURING THE PROCEDURE WERE UNCLAMPED IN ORDER TO RE-WARM THE PT. NO ISSUES WERE NOTED. AFTER THE CASE, DURING TEAR-DOWN, BLOODY WATER WAS NOTED COMING OUT OF THE OXYGENATOR HEAT EXCHANGER AS IT WAS REMOVED FROM THE BRACKET. THE PT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNIV OF VA CHARLOTTESVILLE VA1	CUSTOM PERFUSION PACK	DWE	SORIN GROUP USA, INC.	NA	1101100058

Patients

Seq	Age	Sex	Outcome	Treatment
1