FDA Adverse Event Death Summary report: N

CENTRIFUGAL BLOOD PUMP WITH WITH PC COATING

MDR report key: 2715818 · Received August 21, 2012

Report

Report Number: 1718850-2012-00951
Event Type: Death
Date Received: August 21, 2012
Date of Event: July 19, 2012
Report Date: July 27, 2012
Manufacturer: SORIN GROUP ITALIA
Product Code: KFM
PMA / PMN Number: K030462
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL BLOOD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING AN ECMO CASE, THERE WAS A DROP IN BLOOD FLOW AND ARTERIAL SATURATION. A LOUD NOISE WAS HEARD COMING FROM THE CENTRIFUGAL PUMP. THE PUMP DRIVER WAS HAND CRANKED TO MAINTAIN BLOOD FLOW. FLOW RETURNED TO NORMAL AFTER THE DISPOSABLE WAS CHANGED OUT. THE PT INVOLVED IN THIS CASE EXPIRED BUT IT WAS REPORTED THAT THERE WAS NO LINK BETWEEN THE ISSUE WITH THE DEVICE AND THE DEATH. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

SORIN GROUP RECEIVED A REPORT THAT DURING AN ECMO CASE, THERE WAS A DROP IN BLOOD FLOW AND ARTERIAL SATURATION. A LOUD NOISE WAS HEARD COMING FROM THE CENTRIFUGAL PUMP. THE PUMP DRIVER WAS HAND CRANKED TO MAINTAIN BLOOD FLOW. FLOW RETURNED TO NORMAL AFTER THE DISPOSABLE WAS CHANGED OUT. THE PT INVOLVED IN THIS CASE EXPIRED BUT IT WAS REPORTED THAT THERE WAS NO LINK BETWEEN THE ISSUE WITH THE DEVICE AND THE DEATH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CENTRIFUGAL BLOOD PUMP WITH WITH PC COATING	CENTRIFUGAL BLOOD PUMP	KFM	SORIN GROUP ITALIA	NA	110624009

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death