BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1862695 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04249
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DWELL 3 OF 4 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE PATIENT STATED SHE WAS STILL CONNECTED AND ONE OF THE SUPPLY BAGS FELL AND DISCONNECTED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. LABEL REVIEW WAS NOT PERFORMED NO USER ERROR WAS SUSPECTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 3 OF 4. THE HP STATED SHE WAS STILL CONNECTED AND ONE OF THE SUPPLY BAGS FELL AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ASSISTED THE HP TO CLEAR THE ALARM. THE HP CONFIRMED SHE WOULD FINISH THERAPY WITH A MANUAL BAG. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE OPERATOR DISCOVERED A LEAK UNDERNEATH THE COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS ISOLATED TO THE CORRESPONDING TUBING, WHICH CARRIES THE VACUUM FOR THE PROBE AND NEEDLE DRAIN, AS WELL AS THE LYSE RESTRICTOR TUBING. LYSE REAGENT AND BLOOD PRODUCTS ARE CARRIED THROUGH THIS TUBING. THERE WAS NO EXPOSURE TO SKIN, EYES, OPEN LESIONS OR MUCOUS MEMBRANES. NO MEDICAL TREATMENT WAS SOUGHT BY THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR