FDA Adverse Event Death Summary report: N

BIO-PUMP

MDR report key: 75146 · Received March 5, 1997

Report

Report Number: 2124837-1997-00004
Event Type: Death
Date Received: March 5, 1997
Date of Event: February 4, 1997
Report Date: March 5, 1997
Manufacturer: MEDTRONIC BIO-MEDICUS, INC.
Product Code: KFM
Removal / Correction Number: NA
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFORMATION HAS BEEN RECEIVED SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILED WITH FDA INDICATING THAT THE PATIENT EXPIRED NINE DAYS AFTER BEING WEANED FROM BYPASS SUPPORT. THE DEVICE LISTED IN THE INITIAL REPORT 2124837-1997-4, BP-50 PUMP, S/N 213490, AND THE DEVICES LISTED IN MEDWATCH REPORTS 2124837-1997-2 BP-50 PUMP S/N 21394, AND 2124837-1997-3, BP-50 PUMP S/N 21387 WERE ALL USED ON THE SAME PATIENT. PATIENT'S FAMILY ALLEDGES THAT THE DEVICE MALFUNCTION MAY HAVE CONTRIBUTED OR CAUSED THE OUTCOME. THE SURGEON INDICATED THAT EVEN THOUGH CHANGING THE PUMPHEADS WAS INCONVENIENT AND AND NOT IDEAL, THE AVAILABILITY OF THE PUMP KEPT THE CHILD ALIVE AND HEART RECOVERED. THE CHILD DIED OF SEPSIS POST WEANING. REFER TO SECTION A & B FOR PATIENT INFORMATION.

Description of Event or Problem · 1

HOSP REPORTED THAT FOLLOWING 36 HOURS OF BYPASS SUPPORT, THE PUMP BEGAN TO MAKE NOISES. THE PUMP WAS CHANGED OUT, AND CASE WAS CONTINUED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BIO-PUMP	EXTRACORPOREAL CENTRIFUGAL BLOOD PUMP	KFM	MEDTRONIC BIO-MEDICUS, INC.	BP-50	071492

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 MO		Death