BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1832355 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03368
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 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). THIS REPORT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THE 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). THE SAMPLE WAS DISCARDED, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A LOW DRAIN VOLUME ALARM WITH BAXTER'S TECHNICAL SERVICE CENTER, A HOME PATIENT (HP) SAW A FEW AIR BUBBLES IN THE LINE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(4) 2010. ACCORDING TO THE PATIENT, SHE FORGOT TO OPEN THE CLAMP DURING THE INITIAL DRAIN. THE TSR EXPLAINED TO HER THAT AIR HAD GOTTEN INTO THE LINE BECAUSE THE CLAMP WAS NOT OPEN. THE PATIENT STATED THAT SHE STARTED OVER WITH NEW SUPPLIES. THE PATIENT DID NOT SEE ANY HOLES OR LEAKS IN THE CASSETTE OR TUBING. THE PATIENT RESUMED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR