BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2862741 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06725
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THE PROBLEM COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS (CLB) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 3 OF 3. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THE HOME PATIENT (HP) WAS CURRENTLY IN THE HOSPITAL USING THEIR HC. THE TSR ALSO DETERMINED THE HP HAD 3 BAGS CONNECTED TOTAL, 1 ON THE RED, 1 ON THE WHITE AND 1 ON THE BLUE. THERE WAS SOLUTION PARTIALLY IN THE WHITE AND BLUE. THE TSR STARTED TO TROUBLESHOOT THE BLUE CLAMP BAG WHEN THE HP STATED IT BECAME DISCONNECTED (THIS MEDWATCH COVERS THE DISCONNECTION) AND HE CONNECTED IT BACK. THE TSR EXPLAINED THEN THE SETUP HAD BEEN COMPROMISED AND HE COULD BE RISKING HIMSELF AND INFECTION. THE TSR ASSISTED THE HP WITH ENDING THERAPY. THE TSR ADVISED THE HP TO DISPOSE OF THE CURRENT SUPPLIES ATTACHED AND NOTIFY THE REGISTERED NURSE (RN) RIGHT AWAY REGARDING THE BAG DISCONNECTING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE RECEIVED A CALL FROM THE HOME PATIENT ON (B)(6) 2012 AND HE SAID HE WAS NOT SURE HOW THE BAG BECAME DISCONNECTED. HE SAID HE WAS IN THE HOSPITAL NOW AND THEN, AND THAT A NURSE HAD HOOKED UP ALL THE SUPPLIES FOR HIM. HE DID NOT NOTICE ANYTHING WRONG WITH ANY OF THE PREVIOUS SUPPLIES. HE ENDED THERAPY THAT DAY AND STARTED OVER WITH NEW SUPPLIES. SINCE THEN HE HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE