BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1943134 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07439
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT (H10I14083), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A FOLLOW UP FOR AN UNRELATED ALARM COMPLAINT ON ((B)(6) 2010) THE PATIENT INDICATED HE HAD AN INFECTION IN HIS PERITONEUM. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ON (B)(4) 2010 FROM ONE OF THE PATIENT'S PERITONEAL DIALYSIS (PD) NURSES: THE PATIENT IS ON AND CONTINUES WITH PERITONEAL DIALYSIS . ON (B)(6) 2010, THE PATIENT REPORTED ABDOMINAL PAIN AND CLOUDY EFFLUENT DURING HIS CLINIC VISIT. THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6) 2010. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. ON (B)(6) 2010, THE PATIENT CALLED THE CLINIC TO REPORT THE ABDOMINAL PAIN AND CLOUDY EFFLUENT EVENTS WERE GETTING WORSE. THE PATIENT WENT TO THE EMERGENCY ROOM, AND WAS ADMITTED TO THE HOSPITAL THE SAME DAY. THE ADMITTING DIAGNOSIS WAS PERITONITIS. THE PATIENT RECEIVED IP ANTIBIOTICS DURING HIS HOSPITAL STAY. ON (B)(6) 2010, THE ABDOMINAL PAIN AND CLOUDY EFFLUENT EVENTS WERE RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT CONTINUED TO TAKE IP ANTIBIOTICS AFTER HIS DISCHARGE FROM THE HOSPITAL. ON AN UNKNOWN DATE IN (B)(6) 2010, THE PATIENT COMPLETED HIS IP ANTIBIOTIC REGIMEN. PER THE NURSE, THE PERITONITIS EVENT HAS BEEN RESOLVING. THE PERITONITIS EVENT WAS RELATED TO THE PATIENT NOT CONSISTENTLY WASHING HIS HANDS, AND NOT WEARING A MASK WHILE PREPARING FOR HIS PERITONEAL DIALYSIS (PD) THERAPY. RETRAINING WAS PERFORMED SHORTLY AFTER THE PATIENT?S DISCHARGE FROM THE HOSPITAL. THE ABDOMINAL PAIN, CLOUDY EFFLUENT, AND PERITONITIS EVENTS WERE NOT RELATED TO THE PD SOLUTION OR DEVICES. ALL AVAILABLE INFORMATION WAS REPORTED. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R LOCAL (PD4) AMBUFLEX AND EXTRANEAL