FDA Adverse Event Malfunction Summary report: N

UNKNOWN

MDR report key: 2113 · Received January 5, 1993

Report

Report Number: 2113
Event Type: Malfunction
Date Received: January 5, 1993
Date of Event: December 14, 1992
Report Date: December 15, 1992
Manufacturer: PALL BIOMEDICAL PRODUCTS CORPORATION
Product Code: CAK
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

DECEMBER 14, 1992, PATIENT WITH IMED IN PLACE, WHEN RN ATTEMPTED TO INFUSE RED BLOOD CELLS THROUGH IMED, DRIP CHAMBER ON PALL FILTER COLLAPSED IN ON ITSELF AND BLOOD WOULD NOT GO THROUGH. IV WAS PATEND AND INFUSED IV FREELY. RN CHANGED FILTER TO ANOTHER PALL. TRANSFUSION COMPLETED. THERE WAS NO PATIENT INJURYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN	BLOOD FILTER	CAK	PALL BIOMEDICAL PRODUCTS CORPORATION		169242

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Other