BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 764428 · Received September 8, 2006

    Report

    Report Number
    1423500-2006-01003
    Event Type
    Injury
    Date Received
    September 8, 2006
    Date of Event
    August 21, 2006
    Report Date
    September 8, 2006
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER'S PRODUCT SURVEILLANCE DEPT IS PURSUING ADDITIONAL INFO REGARDING THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A HOME PT (HP) CONTACTED BAXTER'S TECHNICAL SVC CTR REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE DISPLAY OF THEIR HOMECHOICE MACHINE DURING INTIAL DRAIN. PER INITIAL REPORT, THE HOME PT DISCONNECTED/ RECONNECTED THEIR TRANSFER SET FROM THE PT LINE DURING THERAPY. THE BAXTER TECHNICAL SVC REP INSTRUCTED THE HOME PT TO RECYCLE POWER, DISCARD USED SUPPLIES, AND START THERAPY OVER USING NEW SUPPLIES. DURING A FOLLOW UP PHONE CALL REGARDING THE INITIAL 2240 ALARM, A BAXTER PRODUCT SURVEILLANCE SPECIALIST WAS NOTIFIED BY THE HOME PTS PERITONEAL DIALYSIS (PD) NURSE THAT THE HOME PT WAS TREATED FOR PERIONITIS (DIAGNOSIS DATE UNK) AND WAS DISCHARGED FROM THE HOSP IN 2006. THE HOME PT HAS MADE A FULL RECOVERY AND IS SCHEDULED TO VISIT THEIR PD IN FIVE DAYS. THE PD NURSE DOES NOT HAVE ACCESS TO LAB RESULTS, DIAGNOSIS COMMENTS, OR TREATMENT NOTES. THE HP'S NURSE WILL ATTEMPT TO OBTAIN THE HARD COPY OF THE HP'S DISCHARGE PAPERS / MEDICAL RECORD FROM THE ADMITTING HOSP AND FAX THE INFO TO BAXTER'S PRODUCT SURVEILLANCE BY 09/13/2006. NO FURTHER INFO IS AVAILABLE AT THIS TIME; AN ONGOING INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG APD DISPOSABLES HOMECHOICE FKY BAXTER HEALTHCARE NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R CAPD TRANSFER SET| (REFURBISHED)| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT| DIANEAL SOLUTION (STRENGTH UNK)