BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW RECIRCULATION VOLUME APOSET W/CASSETTE

    MDR report key: 1942175 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07411
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF 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. 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. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP)'S CAREGIVER (CG) CONTACTED BAXTER GLOBAL TECHNICAL SERVICES REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING DWELL 11 OF 12. PER THE INITIAL REPORT, THE SUPPLY BAG FELL AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO END THERAPY AND ADVISED TO CONTACT THE NURSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP WITH THE CG REGARDING THE REPORTED PROBLEM, IT WAS REVEALED THAT AN OVERNIGHT NURSE WHO WAS STAYING WITH THE HP AT THE TIME HAD NOTICED THAT THE SUPPLY BAG DROPPED TO THE FLOOR AND STATED THAT SHE MUST HAVE ACCIDENTALLY KNOCKED IT DOWN DURING THE MIDDLE OF THE NIGHT. THE CG STATED THAT THE NURSE INFORMED HIM THAT MORNING AND SO HE CALLED BAXTER AND THEY ADVISED HIM TO END THERAPY AND CONTACT THE PERITONEAL DIALYSIS (PD) NURSE. THE CG STATED THAT HE WAS ABLE TO END THE THERAPY, MANUALLY DRAINED THE HP, THEN HE CONTACTED THE PD NURSE. THE CG ADDED THAT THE HP WAS GIVEN PROPHYLACTIC ANTIBIOTIC AS A PRECAUTION AND WAS MONITORED FOR ANY SIGNS OF INFECTION. PER CG, THE HP DID NOT HAVE ANY SIGNS OF INFECTIONS AND IS CONTINUING WITH THERAPY AS USUAL. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW RECIRCULATION VOLUME APOSET W/CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO HC CYCLER