BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2171704 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09289
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 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 COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN LINE ALARM) WAS NOT CONFIRMED. THE ROOT CAUSE WAS USE ERROR. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL. (B)(4) EXPLAINED THE ALARM INDICATED AIR IN THE CASSETTE. HP HAD DISCONNECTED DURING DWELL, BUT SAID SHE PRESSED STOP AND PUT A CAP ON THE PATIENT LINE. (B)(4) ASSISTED THE HP TO CLEAR THE ALARM BY CYCLING POWER. (B)(4) ADVISED THE HP TO CONTACT THE NURSE. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE HP WHO SAID THAT SHE TRULY BELIEVED IT WAS HER ERROR. THE HP SAID SHE THOUGHT SHE DID EVERYTHING RIGHT, BUT SAID SHE WAS HALF ASLEEP. THE HP SAID SHE WAS SURE THERE WAS NOT A PROBLEM WITH ANY OF THE SUPPLIES AND THAT IT WAS HER FAULT. THE HP SAID THERAPY WAS GOING WELL SINCE AND SHE HAD NOT HAD ANY PROBLEMS SINCE. THE HP DID NOT NOTIFY HER NURSE, BUT SAID SHE WAS GOING TO SEE HER TOMORROW AND WAS GOING TO TELL HER. THE PATIENT WAS ENCOURAGED TO NOTIFY THE NURSE WHEN AIR WAS DETECTED IN THE SETUP. THE PATIENT WAS INVOLVED, BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION 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 37 YR HOMECHOICE