FDA Adverse Event Malfunction Summary report: N

HCSG MIDWEST REG LEXINGTON KY1

MDR report key: 1612548 · Received February 16, 2010

Report

Report Number: 1718850-2010-00004
Event Type: Malfunction
Date Received: February 16, 2010
Date of Event: January 19, 2010
Report Date: January 19, 2010
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: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PRIMO2X OXYGENATOR IS MANUFACTURED BY SORIN GROUP (B)(4). THE 510(5) NUMBER IS K050447. THE DEVICE IS A COMPONENT OF HEART LUNG PACK #(B)(4). DURING THE PROCEDURE, THE PERFUSIONIST EXPERIENCED LOW PO2S. (B)(4) THE UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORT OF PATIENT INJURY. ONE PRIMO2X OXYGENATOR WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY DEFECTS. LABORATORY TESTING WAS PERFORMED TO EVALUATE OXYGEN AND CARBON DIOXIDE GAS TRANSFER. A CONTROL UNIT WAS ALSO TESTED FOR COMPARISON. LABORATORY TESTING SHOWED THAT THE RETURNED UNIT WAS COMPARABLE TO THAT OF THE CONTROL UNIT. THE RESULTS INDICATE THAT THE RETURNED PRIMO2X OXYGENATOR WAS MANUFACTURED PROPERLY. THE REPORTED PROBLEM COULD NOT BE REPRODUCED. THE OXYGENATOR HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR FURTHER ANALYSIS. A FOLLOW-UP REPORT WILL BE FILED WHEN THEIR INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

DURING THE PROCEDURE, THE PERFUSIONIST EXPERIENCED LOW PO2S. TWO UNITS OF BLOOD WERE GIVEN TO COMPENSATE. THE PRIMO2X OXYGENATOR WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORT OF PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HCSG MIDWEST REG LEXINGTON KY1	CUSTOM PERFUSION PACK	DWE	SORIN GROUP USA, INC.	NA	0932100071

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR