FDA Adverse Event Death Summary report: N

CP87170 DE MUENCHEN

MDR report key: 2172002 · Received July 15, 2011

Report

Report Number: 1718850-2011-00078
Event Type: Death
Date Received: July 15, 2011
Date of Event: June 10, 2011
Report Date: June 17, 2011
Manufacturer: SORIN GROUP ITALIA
Product Code: DTZ
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B)(4) MANUFACTURES THIS CUSTOM PERFUSION PACK. THE D100 OXYGENATOR AND D130 ARTERIAL FILTER ARE COMPONENTS OF THE CUSTOM PERFUSION PACK. THE D100 AND D130 ARE SOLD IN THE UNITED STATES. THE 510(K) NUMBER FOR THE D100 IS K061031 AND THE 510(K) NUMBER FOR THE D130 IS K063255. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, AFTER 32 MINUTES OF BYPASS, CLOTS WERE SEEN IN THE D100 OXYGENATOR/RESERVOIR AND THE D130 ARTERIAL FILTER. THE SYSTEM WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. IT WAS REPORTED THAT THE PT DIED AFTER THE OPERATION DUE TO CARDIAC INFARCTION. SORIN GROUP (B)(4) HAS RECEIVED THE PRODUCT FOR EVAL. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

SORIN GROUP (B)(6) RECEIVED A REPORT THAT, AFTER THIRTY TWO MINUTES OF BYPASS, CLOTS WERE SEEN IN THE OXYGENATOR/RESERVOIR AND THE ARTERIAL FILTER. THE SYSTEM WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. IT WAS REPORTED THAT THE PT DIED AFTER THE OPERATION DUE TO CARDIAC INFARCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CP87170 DE MUENCHEN	CUSTOM PERFUSION PACK	DTZ	SORIN GROUP ITALIA	NA	1103150121

Patients

Seq	Age	Sex	Outcome	Treatment
1	2 MO		Death