BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1901372 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05881
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS EVENT WAS DUE TO POOR ASEPTIC TECHNIQUE. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE. PER THE INITIAL REPORT, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT. ON AN UNREPORTED DATE THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT WITH DIANEAL PD4 AMBUFLEX, 2.4 LITERS/4 CYCLES WITH A LAST FILL OF 2 LITERS (FREQUENCY NOT REPORTED) (TOTAL DAILY FILL 11.6 LITERS), AND DIANEAL PD4 ULTRABAG, 2 LITER MIDDAY CYCLE, INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD) AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, A SAMPLE OF PERITONEAL EFFLUENT WAS CULTURED AND A GRAM STAIN WAS PERFORMED TO SEE IF THE PREVIOUS EVENT OF BACTERIAL PERITONITIS HAD RESOLVED. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS. THE NURSE REPORTED THAT THIS WAS A DIFFERENT BACTERIA FROM THE FIRST EPISODE OF PERITONITIS. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT WAS TREATED WITH VANCOMYCIN IP (DOSE, FREQUENCY AND ADMINISTRATION DATES NOT REPORTED). THERE WAS NO EVIDENCE OF A TUNNEL OR EXIT SITE INFECTION. ON (B)(6) 2010, THE PATIENT HAD A REPEAT GRAM STAIN PERFORMED. THE RESULTS SHOWED GRAM POSITIVE WITH 4 (FEW) WBC(S). AT THE TIME OF REPORTING, THE BACTERIAL PERITONITIS RESOLVED. ON (B)(6) 2010, THE PATIENT COMPLETED ANTIBIOTIC THERAPY. THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS UNKNOWN, BUT THE NURSE BELIEVED THAT THERE WAS POSSIBLE CONTAMINATION. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS NOT INTERRUPTED AND THE DOSAGE WAS NOT CHANGED. THE NURSE BELIEVED THAT THE EVENT OF BACTERIAL PERITONITIS WAS NOT RELATED TO DIANEAL THERAPIES. THE PATIENT'S MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD), HYPERTENSION, HEART DISEASE, HEART FAILURE, HEART ATTACK AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR PROTEUS KOSERI AND GRAM STAIN POSITIVE FOR RARE GRAM POSITIVE COCCI IN PAIRS (B)(4). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. A SEARCH OF (B)(4) FOR SUSPECT PRODUCTS SHIPPED WITHIN TWO MONTHS BEFORE THE INCIDENT SHOWED THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MINI-INVASIVE DISCECTOMY PROCEDURE AT L5-S1 TWO YEARS AGO AND A ILLUMINATE SYSTEM WAS USED AT THE SURGERY. DURING THE SURGERY, THE LIGHT SOURCE WHERE IT PLUGS IN WAS DRAPED ACROSS THE PATIENT. AFTER THE SURGERY, IT WAS NOTICED THAT THE PATIENT'S BACK BURNED BY THE CONNECTOR BETWEEN LIGHT SOURCE AND THE CABLE. THE BURN AREA WAS TREATED IN THE OR BEFORE THE PATIENT LEFT THE ROOM. THERE WAS A CIRCLE MARK LEFT WHERE THE PLUG WAS DRAPED OVER THE PATIENT. THE PATIENT REPORTEDLY RECEIVED THE POST-OP TREATMENT FOR THE BURN. REPORTEDLY, THE PATIENT HAD THE DERMATOLOGY ISSUES AFTER THE TREATMENT.

    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 85 YR Required Intervention DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG