BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1790120 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02310
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 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). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS COMPLAINT. 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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT AND REVIEWED PROPER PROCEDURES. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM (AIR IN LINE), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 2. THE HOME PATIENT STATED THE SUPPLY LINE CLAMP WAS OPEN AND SHE DOES NOT USE THAT LINE. THE HP WAS ADVISED TO START OVER WITH ALL NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER FRANCE THAT THE RESERVOIR OF ONE (1) CE INTERMATE LV250 HAD RUPTURED DURING PATIENT USE. ACCORDING TO THE REPORT, THE INTERMATE WAS FILLED WITH 125ML OF TICARCILLINE (CLAVENTIN) 5G/200MG AND SODIUM CHLORIDE AND THE RUPTURE WAS OBSERVED 10 MINUTES AFTER THE START OF INFUSION. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROPI ES RESULTS FOR TWO DIFFERENT PATIENT SAMPLES PROCESSED ON A VITROS ECIQ INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. ONE OF TWO TROPI ES RESULTS WAS REPORTED OUTSIDE THE LABORATORY. A CORRECTED REPORT WAS SENT TO THE PHYSICIAN AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    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 46 YR