FDA Adverse Event Malfunction Summary report: N

HCSG/HENDRICK MED/ABLNE TX 1

MDR report key: 1612547 · Received February 16, 2010

Report

Report Number: 1718850-2010-00010
Event Type: Malfunction
Date Received: February 16, 2010
Date of Event: January 15, 2010
Report Date: January 26, 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: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B) (4) MANUFACTURES THE SYNTHESIS OXYGENATOR. THE 510(K) NUMBER IS K073380. THE DEVICE IS A COMPONENT OF HEART LUNG PACK (B) (4). OUR USED SYNTHESIS OXYGENATOR WAS RECEIVED AT SORIN GROUP USA FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE GAS INLET CAP HAD VOIDS OR HOLES IN TWO LOCATIONS. THIS DEFECT WOULD ALLOW GAS TO ESCAPE DURING USE. LABORATORY TESTING CONFIRMED THE REPORTED HIGH PCO2 VALUES WHEN TESTED WITH THE VOIDS OR HOLES UNCOVERED. WITH THE HOLES SEALED, NO GAS EXCHANGE ISSUES WERE NOTED. THE OXYGENATOR HAS BEEN RETURNED TO SORIN GROUP (B) (4) FOR FURTHER ANALYSIS. A FOLLOW-UP REPORT WILL BE FILED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem · 1

AT THE START OF BYPASS, THE PERFUSIONIST REPORTED EXPERIENCING HIGH PCO2S DURING THE PROCEDURE. THE PERFUSIONIST ATTEMPTED TO RESOLVE THE ISSUE BY 100% VENTILATION, INCREASING THE SWEEP GAS AND REPLACING GAS DELIVERY LINE AND FILTERS. THE PATIENT WAS WEANED FROM BYPASS AND VENTILATED BY ANESTHESIA WHILE THE OXYGENATOR WAS CHANGED OUT. THE PATIENT REMAINED STABLE DURING THE CHANGE. NO FURTHER PROBLEMS WERE ENCOUNTERED. PATIENT WAS REPORTED TO BE FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HCSG/HENDRICK MED/ABLNE TX 1	CUSTOM PERFUSION PACK	DWE	SORIN GROUP USA, INC.	NA	0930000037

Patients

Seq	Age	Sex	Outcome	Treatment
1