BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2201029 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10560
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER (H11D15023, H11B13063, AND H11C24019 ) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A CALL TO THE BAXTER (B)(4), THE PATIENT INDICATED HE MAY HAVE AN INFECTION AND WAS ADVISED BY THE FACILITY NURSE, TO ADD MEDICATION TO THE PERITONEAL DIALYSIS (PD) SOLUTION. A FOLLOW UP CALL WAS MADE TO THE FACILITY NURSE ON (B)(6) 2011, WHO CONFIRMED THE PATIENT HAD BEEN DIAGNOSED WITH PERITONITIS. ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT WAS HOSPITALIZED. THE PATIENT IS CURRENTLY OFF PD AND IS RECEIVING HEMODIALYSIS UNTIL HIS ABDOMINAL AND INTENSIONAL ISSUES (UNKNOWN) ARE RESOLVED. SUSPECT LOTS: H11D15023, H11B13063, AND H11C24019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R DIANEAL LOW CAL, ULTRA BAG DEXTROSE 4.250%| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 1.50%| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 2.50%| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 4.250%| HOMECHOICE| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 2.50%