BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2834040 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05268
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. THIS COMPLAINT FOR PERITONITIS-NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER, THERE WAS NO LOT NUMBER GIVEN AND NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE WERE REPORTED. THE COMPLAINT INVESTIGATION DID NOT DESCRIBE ANY TYPES OF USE ERRORS THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. THEREFORE THE COMPLAINT IS NOT CONFIRMED AND THE ASSIGNABLE CAUSE IS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED FOR THE SUSPECT LOTS AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND 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

    ON (B)(6) 2012, THE HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A AN UNRELATED COMPLAINT. DURING THE CONVERSATION, THE HP REPORTED HE HAD AN INFECTION AND THAT HIS REGISTERED NURSE WAS AWARE OF IT. ON (B)(6) 2012, PRODUCT SURVEILLANCE SPOKE WITH THE PERITONEAL DIALYSIS NURSE REGARDING THE REPORTED EVENT. THE FOLLOWING INFORMATION WAS REPORTED. IN 2011, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED PANCREATITIS AND WAS HOSPITALIZED FOR THE EVENT. TREATMENT DURING HOSPITALIZATION INCLUDED UNSPECIFIED ANTIBIOTIC TREATMENT. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2012, APPROXIMATELY ONE WEEK AFTER HOSPITALIZATION, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND WAS RE-HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH DAPTOMYCIN INTRAPERITONEALLY (IP). AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT REMAINED HOSPITALIZED. PD THERAPY WAS ONGOING THROUGHOUT BOTH HOSPITALIZATIONS. THE PATIENT WAS RECOVERING FROM PERITONITIS. THE NURSE STATED THE HOSPITALIZATION FOR PANCREATITIS CAUSED THE PATIENT TO GET PERITONITIS. THE NURSE STATED THE EVENT OF PERITONITIS WAS UNRELATED TO ANY BAXTER SOLUTIONS, DISPOSABLES OR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 2.50%| (B)(4) DIANEAL LOW CAL, ULTRA BAG DEXTROSE 4.25%| (B)(4) DIANEAL LOW CAL, ULTRA BAG DEXTROSE 1.50%| (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 4.25%| (B)(4) DIANEAL LOW CAL, ULTRA BAG DEXTROSE 2.50%| (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%