BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1992063 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01991
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 22, 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 AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. 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). THIS COMPLAINT IS FOR A REPORT OF A USER ERROR. PER THE COMPLAINT INFORMATION, THE PATIENT REQUESTED INSTRUCTIONS ON RE-PRIMING HOWEVER WERE IN FILL 1 OF 4. PATIENT WAS CONNECTED. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION THE CAUSE OF THE COMPLAINT IS USER ERROR/ MIS-USE. THE LOT NUMBER IS UNKNOWN, THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CALLER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER NEEDING ASSISTANCE TO RE-PRIME THE PATIENT LINE, WHICH OCCURRED ON THE HOMECHOICE (HC), DURING USE DURING THE INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT THEY WERE TRYING TO COLLECT A SAMPLE OF DRAINED FLUID TO TAKE TO THEIR NURSE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH TROUBLESHOOTING AND ADVISED THE HP TO END THE THERAPY AND START AGAIN WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE MACHINE