BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022767 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03352
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. 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 RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A LOW DRAIN VOLUME ALARM, THE HOME PATIENT (HP) STATED THEY SAW AIR IN THE SUPPLY LINE THAT WAS NOT BEING USED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP IF ALL THE CLAMPS WERE CLOSED AND THE HP STATED YES. THE TSR ADVISED THE HP THAT THEY WOULD NEED TO START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. A FOLLOW UP WAS DONE VIA PHONE CALL. THE HP SAID THAT THEY ALWAYS FOLLOW THE PROCEDURE AND HE HAD NO IDEA HOW AIR GOT INTO THE PATIENT LINE. THE HP SAID THAT HE DID NOT NOTICE ANYTHING UNUSUAL WITH ANY OF THE SUPPLIES. THE LOT NUMBER WAS UNKNOWN AND NO SAMPLES WERE AVAILABLE. THE HP SAID HE NOTIFIED HIS NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 62 YR HOMECHOICE