FDA Adverse Event Malfunction Summary report: N

HEPARIN INFUSION LINE

MDR report key: 4526 · Received January 8, 1993

Report

Report Number: 4526
Event Type: Malfunction
Date Received: January 8, 1993
Date of Event: October 7, 1992
Report Date: October 19, 1992
Manufacturer: NATIONAL MEDICAL CARE, INC. - MEDICAL PRODUCTS DIV.
Product Code: FPB
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ON 10/7/92, WHILE PERFORMING DIALYSIS ON A PATIENT, IT WAS NOTED THAT THERE WAS APPROXIMATELY A 60 CC BLOOD LOSS FROM THE HEPARIN INFUSION LINE. THE LINE WAS NOT CONNECTED TO AN INFUSION. YOU REPORTED THAT FUTURISTICALLY A CLAMP WILL BE AVAILABLE FOR THIS SEGMENT OF LINE. IN THE INTERIM WE ARE CHANGING PROCEDURE SO THAT A CLAMP IS PLACED ON THIS LINE TO PREVENT RECURRENCE OF THIS PROBLEMINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HEPARIN INFUSION LINE		FPB	NATIONAL MEDICAL CARE, INC. - MEDICAL PRODUCTS DIV.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other