FDA Adverse Event Injury Summary report: N

SMART PERFUSION PACK: APEX MBR FMC/MID WEST REG LEXINGTON, KY

MDR report key: 2228591 · Received September 11, 2007

Report

Report Number: 1718850-2007-00014
Event Type: Injury
Date Received: September 11, 2007
Product Code: DTZ
PMA / PMN Number: PREAMENDMENT
Removal / Correction Number: NA
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER WOULD NOT SUPPLY THIS INFO. THE 510(K) NUMBER FOR THE LEFT VENT VALVE IS K982406. IT IS MANUFACTURED BY SORIN GROUP USA, INC. AND IS A COMPONENT IN THE CUSTOM PERFUSION PACK MANUFACTURED BY SORIN GROUP USA, INC. THE CUSTOM PERFUSION PACK, CATALOG NUMBER 084110300, IS A PRE-AMENDMENT DEVICE. RESULTS: VISUAL INSPECTION OF THE RETURNED PARTS REVEALED THAT THE LEFT VENT VALVE WAS ASSEMBLED TO THE CORRECT TUBING AND ORIENTED IN THE PROPER DIRECTION OF FLOW. PERFORMANCE TESTING SHOWED THE VALVE OPERATED CORRECTLY, PERMITTING FLUID FLOW IN THE FORWARD DIRECTION AND BLOCKING FLOW IN THE REVERSE DIRECTION. THE TESTING ALSO SHOWED THAT BOTH THE OVER PRESSURE AND VACUUM RELIEF FUNCTIONS OPERATED CORRECTLY. NO DEFECTS WERE FOUND WITH EITHER THE ASSEMBLY OR THE OPERATION OF THE VALVE. THE ALLEGED FAILURE OF THE LEFT VENT VALVE COULD NOT BE DUPLICATED. DEATH (SUBSEQUENT CONVERSATION WITH RISK MANAGEMENT INDICATED THE PT HAD EXPIRED).

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SMART PERFUSION PACK: APEX MBR FMC/MID WEST REG LEXINGTON, KY	CUSTOM PERFUSION PACK	DTZ		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1