FDA Adverse Event Other Summary report: N

WA ADVENT TAKOMA PARK MD 1

MDR report key: 2357598 · Received November 22, 2011

Report

Report Number: 1718850-2011-00224
Event Type: Other
Date Received: November 22, 2011
Date of Event: September 26, 2011
Report Date: October 27, 2011
Manufacturer: SORIN GROUP USA, INC.
Product Code: DTZ
PMA / PMN Number: PREAMENDMENT
Removal / Correction Number: NA
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B)(4) MANUFACTURES THE APEX OXYGENATOR. THE 510(K) NUMBER IS K083021. THE OXYGENATOR IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A REPORT WAS RECEIVED INDICATING THAT BLOOD WAS LEAKING FROM THE GAS OUTLET PORT OF THE OXYGENATOR. THE PERFUSIONIST ELECTED TO CONTINUE TO USE TO COMPLETE THE CASE. BLOOD LOSS WAS APPROXIMATELY 5 CC. THERE WERE NO PT COMPLICATIONS DUE TO THE BLOOD LEAK. THE APEX MEMBRANE MODULE WAS RETURNED TO SORIN GROUP (B)(4). VISUAL INSPECTION FOUND BLOODY FLUID INSIDE THE BLOOD COMPARTMENT AS WELL AS BLOOD RESIDUE ON THE OUTSIDE OF THE BOTTOMS END CAP. LEAK TESTING FOUND COMMUNICATION BETWEEN THE BLOOD AND WATER COMPARTMENTS IN THE OXYGENATOR. AUTOPSY FOUND DRIED BLOOD INSIDE THE WATER COMPARTMENT. THE APEX OXYGENATOR HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR FURTHER ANALYSIS. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

SORIN GROUP RECEIVED A REPORT THAT BLOOD WAS LEAKING FROM THE GAS OUTLET PORT OF THE OXYGENERATOR. THE PERFUSIONIST ELECTED TO CONTINUE TO USE TO COMPLETE THE CASE. BLOOD LOSS WAS APPROXIMATELY 5 CC. THERE WERE NO PT COMPLICATIONS DUE TO THE BLOOD LEAK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	WA ADVENT TAKOMA PARK MD 1	CUSTOM PERFUSION PACK	DTZ	SORIN GROUP USA, INC.	NA	1116700026

Patients

Seq	Age	Sex	Outcome	Treatment
1