FDA Adverse Event Malfunction Summary report: N

SPECTRA

MDR report key: 442330 · Received February 5, 2003

Report

Report Number: 442330
Event Type: Malfunction
Date Received: February 5, 2003
Date of Event: September 11, 2002
Report Date: September 25, 2002
Manufacturer: GAMBRO BCT, INC.
Product Code: LKN
Product Problem: Yes
Report Source: User Facility report
Reporter Location: NC, US
Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 1

TITLE: SPECTRA MALFUNCTION. THIS IS A PT WHO WAS ADMITTED WITH THROMBOTIC THROMBOCYTOPENIA PURPURA AND WAS UNDERGOING PLASMA EXCHANGE. APPROXIMATELY TWO-THIRDS OF THE WAY THROUGH THE EXCHANGE, THE NURSE NOTED THAT THERE WAS A DISCREPANCY BETWEEN THE PATIENT'S OUTPUT AND OUTPUT READING BY THE MACHINE. [THE PLASMA BAG WAS WEIGHED AND THE FLUID BALANCE WAS (+)390CC AT THE END OF THE THERAPEUTIC PLASMA EXCHANGE (TPE). THE MACHINE, AT THAT POINT, INDICATED THE BALANCE WAS OVER 500CC. THE TPE WAS STOPPED, BUT IS NOT KNOWN FOR HOW LONG. IT IS BELIEVED THE TPE WAS RESTARTED AFTER THE DISCREPANCY WAS DISCOVERED AND PROCEDURE COMPLETED. THERE WAS NO SEQUELA TO THE PATIENT AS A RESULT OF THIS INCIDENT.] GAMBRO WAS NOTIFIED, AND A SERVICE REPRESENTATIVE CAME OUT AND RECALIBRATED THE PUMPS. [THE SERVICE REPRESENTATIVE DID NOT IDENTIFY A PROBLEM WITH THE EQUIPMENT. THE QUALITY ASSURANCE DEPARTMENT OF GAMBRO WAS NOTIFIED IN CASE THERE WAS A PROBLEM WITH THE TUBING SET THAT HAD BEEN USED. THE MANUFACTURER HAS NOT PROVIDED ANY ADDITIONAL REPORT TO THE SITE REPORTER TO DATE.] OTHER TUBING SETS FROM THE SAME LOT HAVE BEEN USED WITHOUT INCIDENT. THE MACHINE HAS SINCE BEEN USED WITHOUT INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPECTRA	APHERESIS MACHINE	LKN	GAMBRO BCT, INC.	UNK	UNK
2	*	TPE KIT	GKT	GAMBRO BCT, INC.	*	08H15239

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR		Other	TUBING KIT.