BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2002592 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02514
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 6, 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).EVALUATION SUMMARY:THIS REPORT FOR A CONNECTION ISSUE WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SEPARATION IS DUE TO THE SUPPLY BAG FALLING AND DISCONNECTING. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, BAXTER CANNOT DETERMINE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED THAT A HEATER BAG FELL AND GOT DISCONNECTED DURING FILL 2 OF 3. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AND EXPLAINED THAT THE SUPPLIES ARE COMPROMISED AND HP WILL NEED TO START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE HP TO CALL THE NURSE IN THE NEXT 24 HOURS AND LET HER KNOW WHAT HAPPENED. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(4) 2011. ACCORDING TO THE NURSE THE PATIENT HAS BEEN TO THE CLINIC SINCE THIS EVENT AND WAS ABLE TO RESUME THERAPY SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(4) 2011. THE PATIENT STATED THAT THE BAG WAS NOT SITTING AT THE EDGE OF THE TABLE, BUT SHE THINKS THAT THE CONNECTION WAS LOOSE WHICH CAUSED THE BAG TO GET FULLY DISCONNECTED AND FALL. THE PATIENT NOTIFIED THE NURSE AND DISCARDED THE SUPPLIES. THE PATIENT RESUMED THERAPY WITH NO FURTHER ISSUES.

    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 83 YR HOMECHOICE