BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2100943 · Received May 24, 2011

    Report

    Report Number
    1423500-2011-06419
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 29, 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 SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USER ERROR. THE CARE GIVER STATED SHE DID NOT KNOW WHAT TO DO SO SHE PROCEEDED TO JUST RE-HOOK THE HOME PATIENT (HP) AND CONTINUE THERAPY. A BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER WAS NOT AVAILABLE. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS 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

    THIS REPORT IS FOR USE ERROR. DURING FOLLOW UP FOR AN UNRELATED COMPLAINT ON (B)(6) 2011, CORPORATE PRODUCT SURVEILLANCE (CPS) RECEIVED A REPORT FROM THE CAREGIVER (CG) THAT ON (B)(6) 2011, THE HOME PATIENT (HP) MUST HAVE UNHOOKED THE TUBE DURING THERAPY BECAUSE HE WAS DRENCHED. THE CG STATED SHE DID NOT KNOW WHAT TO DO, SO SHE PROCEEDED TO JUST RE-HOOK THE HP BACK UP AND CONTINUE THERAPY (THIS COMPLAINT). THE CG STATED SHE DID NOT NOTIFY THE REGISTERED NURSE (RN) OF THE INCIDENT. CPS RECOMMENDED CONTACTING THE RN. THE SAMPLE WAS DISCARDED AND THE CG DID NOT KNOW THE LOT NUMBER OF THE SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS 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 76 YR