BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2070045 · Received April 26, 2011

    Report

    Report Number
    1423500-2011-05058
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER REPORTED A LOW DRAIN VOLUME ALARM. PER THE CALL SCRIPT THE ASSIGNABLE CAUSE WAS DETERMINED TO BE AIR IN PATIENT LINE. AS A SAMPLE WAS NOT AVAILABLE FOR EVALUATION AND THE PATIENT DID NOT DESCRIBE ANY TYPE OF USE ERROR THAT MIGHT HAVE CAUSED THE ALARM, THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. 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).

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A LOW DRAIN VOLUME (LDV) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN, THE HOME PATIENT (HP) REPORTED THAT THERE WAS AIR IN PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP IN ENDING THERAPY. THE HP TO RESTART WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW-UP WITH THE HP ON (B)(6) 2011 REGARDING THE REPORTED EVENT, IT WAS REVEALED THAT SHE WAS FINE AFTER AND STARTING OVER AGAIN. THE HP DID CONTACT HER NURSE. THE HP STATED SHE DID NOT HAVE ANY INJURY OR NEED ANY MEDICAL INTERVENTION DUE TO THIS EVENT. SHE STATED THAT SHE HAS BEEN DOING FINE WITH THERAPY.

    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 33 YR HOMECHOICE CYCLER