BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2003230 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02549
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 10, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF CLOUDY EFFLUENT , DIARRHEA, VOMITING AND SEVERE ABDOMINAL PAIN IN A PATIENT COINCIDENT WITH DIANEAL PD4 BAG AND EXTRANEAL VIAFLEX THERAPIES FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2011, THE PATIENT CONTACTED THE PD UNIT TO REPORT THAT HE WAS EXPERIENCING DIARRHEA, VOMITING AND SEVERE ABDOMINAL PAIN. ON THE SAME DAY, THE PATIENT REPORTED THAT HE DRAINED HIS FLUID AND EXPERIENCED CLOUDY EFFLUENT. ON (B)(6) 2011, THE PATIENT PRESENTED TO THE UNIT WITH DIARRHEA, VOMITING AND SEVERE ABDOMINAL PAIN. THE UNIT DRAINED THE REMAINING DWELL OF EXTRANEAL VIAFLEX (LOT NUMBER 10F20G37); WHICH WAS DWELLING FOR 10 HOURS PRIOR THE BEING DRAINED, AND THE ADDITIONAL FLUID WAS REPORTED AS "TURBID". ON AN UNREPORTED DATE, "AS PER PROTOCOL" THE PATIENT BEGAN REMEDIAL THERAPY WITH GENTAMYCIN (40MG, FREQUENCY NOT REPORTED, IP) AND VANCOMYCIN (2G, FREQUENCY NOT REPORTED, IP). THE PATIENT DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2011, REMEDIAL THERAPY WITH CIPROFLOXACIN (500MG, "BD", ORAL) WAS ADDED. ON (B)(6) 2011, THE EVENTS OF CLOUDY EFFLUENT, DIARRHEA, VOMITING AND SEVERE ABDOMINAL PAIN RESOLVED. THE NURSE REPORTED THAT THE PATIENT HAD "CLEAR BAGS AND NO SYMPTOMS". THE NURSE REPORTED DESPITE THE FACT THE PATIENT WAS ASYMPTOMATIC; "THE UNIT INTENDED TO ADMINISTER A SECOND IP DOSE OF VACOMYCIN ON (B)(6) 2011". AT THE TIME OF THIS REPORT, DIANEAL PD4 UNKNOWN BAG AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention EXTRANEAL VIAFLEX| DIANEAL PD4 UNKNOWN BAG