BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2103568 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06548
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 5, 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). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USER 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. COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER 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.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A CHECK LINES AND BAGS ALARM, THE HOME PATIENT (HP) STATED THAT SHE RESTARTED THE SETUP WITH THE SAME SUPPLIES SEVERAL TIMES AND DISCONNECTED THE BAGS THEN RECONNECTED THEM AND IS STILL HAVING THE SAME PROBLEM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO NEVER DISCONNECT THE BAGS FROM THE SETUP AND RECONNECT FOR FEAR OF COMPROMISING THE SETUP. THE TSR ADVISED HP TO CYCLE POWER AND RESTART THE SETUP WITH ALL NEW SUPPLIES. THE HP STATED THAT SHE WAS GOING TO SKIP THE THERAPY FOR TONIGHT. THE TSR ADVISED THE HP TO CALL THEIR NURSE. 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 STATED SHE WAS ABLE TO RESUME THERAPY THE FOLLOWING NIGHT WITH THE NEW SUPPLIES. THE HP DID NOT NOTE ANYTHING UNUSUAL WITH THE SUPPLIES SHE WAS USING. THE HP DISCARDED THE SUPPLIES AND DID NOT PROVIDE THE LOT NUMBER INFORMATION. THE HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATIONS. THERE WAS NO 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 42 YR HOME CHOICE