BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1880651 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04844
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    July 1, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H09J21080, H09K10032, H10A11029, AND H10B01028) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE PT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF HIS BATTERIES WAS UNABLE TO POWER ON THE MONITOR. SUPPORT ISSUED THE PT A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    DURING FOLLOW-UP FOR AN UNRELATED COMPLAINT , THE PATIENT'S CAREGIVER INDICATED THE PATIENT HAD AN INFECTION. ADDITIONAL INFORMATION OBTAINED FROM ONE OF THE PATIENT'S PERITONEAL DIALYSIS (PD) NURSE ON (B)(4) 2010: THE PATIENT STARTED WITH PD THERAPY ON (B)(6) 2009 WITH LOCAL (PD4) AMBUFLEX. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2010 AND WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6) 2010. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THIS PERITONITIS. IT WAS INDICATED THE PATIENT'S PD EFFLUENT WAS ANALYZED ON (B)(6) 2010. THE CELL COUNT SHOWED 2738 LEUCOCYTES, 92% NEUTROPHILS, AND 8% MONOCYTES. THE GRAM STAIN SHOWED POSITIVE RESULTS AND THE CULTURE SHOWED (B)(6). THE PATIENT WAS TREATED WITH VANCOMYCIN AND RECOVERED FROM THE PERITONITIS. THE NURSE INDICATED THAT THE CAUSE OF THE PERITONITIS WAS UNKNOWN; HOWEVER, STATED THAT THE (B)(6) HAD SPREAD FROM OTHER PARTS OF THE PATIENT'S BODY. THE NURSE ALSO INDICATED THAT THIS PERITONITIS EVENT WAS A RECURRENT PERITONITIS FROM ONE THAT BEGAN ON (B)(6) 2010. THE NURSE STATED THAT THE INFECTION RESOLVED AND CAME BACK, BUT SHE WAS UNABLE TO PROVIDE AN EXACT NUMBER OF TIMES THE INFECTION RECURED. THE FOLLOWING INFORMATION PERTAINING TO THE PERITONITIS FROM (B)(6) 2010 WAS OBTAINED ON (B)(4) 2010 AND IS AS FOLLOWS: THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6) 2010 BUT WAS NOT HOSPITALIZED. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. THE PATIENT'S PD EFFLUENT WAS ANALYZED AND THE CELL COUNT SHOWED 1163 LEUCOCYTES, 92% NEUTROPHILS, 2% LYMPHOCYTES, AND 6% MONOCYTES. THE GRAM STAIN SHOWED GRAM POSITIVE COCCI AND THE CULTURE SHOWED (B)(6). THE PATIENT WAS TREATED WITH VANCOMYCIN 2 GRAMS INTRAPERITONEAL AND RECOVERED FROM THE PERITONITIS. THE NURSE AGAIN INDICATED THAT THE CAUSE OF THE PERITONITIS WAS UNKNOWN; HOWEVER, STATED THAT THE (B)(6) HAD SPREAD FROM OTHER PARTS OF THE PATIENT'S BODY. THE NURSE INDICATED THAT AFTER THE DIAGNOSIS OF THIS PERITONITIS, THE PATIENT'S BLUE TWIST CLAMP REGULAR LENGTH TRANSFER SET WAS REPLACED, BUT THAT FOR THE REOCCURRING EVENT IN (B)(6), THE CATHETER WAS JUST REMOVED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION AND THE PATIENT WAS REPORTED TO BE DOING WELL ON HEMODIALYSIS.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R LOCAL (PD4) AMBUFLEX