FDA Adverse Event Other Summary report: N

FR MARSEILLE

MDR report key: 1942914 · Received December 22, 2010

Report

Report Number: 1718850-2010-00179
Event Type: Other
Date Received: December 22, 2010
Date of Event: November 24, 2010
Report Date: November 26, 2010
Manufacturer: SORIN GROUP ITALIA
Product Code: DTZ
PMA / PMN Number: K022450
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B)(4) MANUFACTURES THE SYNTHESIS OXYGENATOR. THE SYNTHESIS OXYGENATOR IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510(K) NUMBER FOR THE SYNTHESIS IS K022450. THIS INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE CLINICIAN REPORTED THAT THE PO2 MEASUREMENTS TAKEN FROM THE SAMPLING LINE WERE INCONSISTENT WITH THOSE MEASURED AT THE ARTERIAL CANNULA. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES BY MEASURING THE PO2 AT THE ARTERIAL CANNULA INSTEAD OF THE SAMPLE LINE. THE SYNTHESIS OXYGENATOR HAS BEEN RECEIVED AT (B)(4) FOR EVAL. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF PT INJURY. THE FACILITY REPORTED THE EVENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

Description of Event or Problem · 1

THE CLINICIAN REPORTED THAT, DURING THE PROCEDURE, THERE WAS A LOW PO2 MEASURED IN THE SAMPLING LINE AND THE BLOOD IN THE ARTERIAL FILTER WAS DARK IN COLOR. THE PO2 MEASURED AT THE ARTERIAL CANNULA WAS OK. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES BY MEASURING THE PO2 AT THE ARTERIAL CANNULA INSTEAD OF THE SAMPLE LINE. THERE WAS NO REPORT OF PT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FR MARSEILLE	CUSTOM PERFUSION PACK	DTZ	SORIN GROUP ITALIA	NA	1009080042

Patients

Seq	Age	Sex	Outcome	Treatment
1