BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX HF1000

    MDR report key: 3288166 · Received August 14, 2013

    Report

    Report Number
    8010182-2013-00007
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 17, 2013
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K042938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    -THE PRISMAFLEX HF1000 FILTER SET HAS BEEN RETAINED BY HEALTH CARE FACILITY AND NOT AVAILABLE FOR INSPECTION BY GAMBRO INDUSTRIES. HOWEVER, THE SET WAS EXAMINED BY THE HOSPITAL AND THERE WAS NO LINE DISCONNECTION FROM THE FILTER AND NO ANOMALIES WERE IDENTIFIED. THE REVIEW OF THE PRISMAFLEX HF1000 FILTER SETS DEVICE HISTORY RECORD WITH LOT NUMBER 13C2905 AND THE COMPLAINT HISTORY FILES HAVE SHOWN THAT THERE WERE NO NONCONFORMITIES AND NO SIMILAR COMPLAINT REPORTED REGARDING THIS LOT NUMBER. THE ENFLOW BLOOD WARMER (COMPETITOR BLOOD WARMER) WAS USED OFF LABEL WITH THE PRISMAFLEX CONTROL UNIT. THE ONLY BLOOD WARMERS APPROVED FOR USE WITH THE PRISMAFLEX ARE PRISMATHERM, PRISMAFLO AND PRISMACOMFORT. THE BLOOD WARMER COULD HAVE CREATED EXTRA WEIGHT ON THE RETURN LINE IF IT WASN'T SUPPORTED WHICH COULD HAVE RESULTED IN A DISCONNECTION. THE DATA FILE ANALYSIS DOES NOT INDICATE ANY FAILURE ON THE PRISMAFLEX CONTROL UNIT AND THE GAMBRO TECHNICAL SERVICE INSPECTION CONFIRMS THE MACHINE WAS OPERATING WITHIN MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 1

    A PATIENT IN THE SICU, RECOVERING FROM A BILATERAL LUNG TRANSPLANT WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY [CRRT]ON A PRISMAFLEX MACHINE WITH A PRISMAFLEX HF1000 FILTER SET. AN ENFLOW BLOOD WARMER WAS CONNECTED DIRECTLY TO THE PATIENT'S ACCESS CATHETER. THE MACHINE GENERATED THE AIR IN BLOOD ALARM AT WHICH TIME THE NURSE OBSERVED AIR IN THE LINE AND CLAMPED THE LINE. SHE ALSO IDENTIFIED THERE WAS A DISCONNECTION OF THE BLOOD WARMER TO THE CATHETER RESULTING IN AN UNDETERMINED BLOOD LOSS. THE PATIENT HAD A CARDIOPULMONARY ARREST AND WAS SUCCESSFUL RESUSCITATED. THE RISK MANAGER STATED THE PATIENT EXPERIENCED A BLOOD LOSS WITH A "FEW GRAM DROP IN HEMOGLOBIN". THE PATIENT WAS TRANSFUSED WITH TWO UNITS OF RED BLOOD CELLS AND ADDITIONAL SUPPORTIVE MEASURES TAKEN AT THIS TIME INCLUDED A FLUID BOLUS, ADMINISTRATION OF IV PRESSORS AND ADJUSTMENT OF THE VENTILATORY SETTINGS. WITHIN EIGHT HOURS, THE PATIENT RETURNED TO HIS BASELINE HEMODYNAMIC STATUS, THE VENTILATORY SETTINGS WERE DECREASED AND THE PATIENT¿S NEUROLOGICAL STATUS WAS GREATER THAN PRIOR TO THIS EVENT. THE PATIENT IS NO LONGER ON CRRT OR VENTILATION SUPPORT. THE RISK MANAGER RECOGNIZED THE BLOOD WARMER USED IN THIS EVENT IS NOT ONE OF THE BLOOD WARMERS APPROVED FOR THE PRISMAFLEX MACHINE. THE PRISMAFLEX MACHINE WAS INSPECTED AND DETERMINED TO BE OPERATING IN ACCORDANCE TO THE MANUFACTURE'S SPECIFICATION. THE MACHINE WAS RETURNED TO SERVICE. THE HF1000 FILTER SET WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED TO GAMBRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389802 PRISMAFLEX HF1000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 107140 13C2905

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening PRISMAFLEX MACHINE, SN (B)(4)