MalfunctionKSW

HAEMOCELL SYSTEM 350

Received Apr 20, 1993 · Event occurred Feb 2, 1993

Report 1811755-1993-00002 · MDR key 5327

Device

Generic name

Autologous Blood Processing System

Manufacturer

Haemocell Plc

Model number

216-350-110

Catalog number

N/A

Lot number

N/A

Narrative

Description of Event or Problem

IT IS ALLEGED THAT THE DEVICE CEASED TO FUNCTION DURING USE, DISALLOWING THE REINFUSION OF 500CC OF A PATIENT'S AUTOLOGOUS BLOOD. NO INJURY WAS REPORTED.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.