BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    MDR report key: 1930775 · Received December 16, 2010

    Report

    Report Number
    6000001-2010-05865
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER CONTACT INDICATED THE SAMPLE IS AVAILABLE FOR EVALUATION, THEREFORE, SAMPLE RETURN HAS BEEN REQUESTED. UPON COMPLETION OF THE SAMPLE EVALUATION, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE AVAILABLE FOR EVALUATION. A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOT, H10A0603, WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. A TREND REVIEW DID NOT REVEAL ANY INCREASING TREND OR PERIOD OF EXCEPTIONAL FREQUENCY OF OCCURRENCE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BAXTER'S CLINICAL EDUCATOR RECEIVED A COMPLAINT REPORT FROM A CUSTOMER WHO REPORTED THAT A MINICAP TRANSFER SET LEAKED ON ONE OF THEIR HOME PATIENTS AND THE PATIENT DEVELOPED PERITONITIS. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2010. THE PERITONEAL DIALYSIS (PD) NURSE REPORTED T THAT THE TRANSFER SET WAS IN USE ON THE HOME PATIENT (HP) SINCE (B)(6) 2010. THE PATIENT HAS BEEN ON AUTOMATED PERITONEAL DIALYSIS (APD) SINCE (B)(6) 2010. THE NURSE STATED THE HOME PATIENT (HP) CAME INTO THE CLINIC ON (B)(6) 2010 WITH PERITONITIS. PER THE NURSE, THE TRANSFER SET WAS LEAKING WHERE THE WHITE TWIST CLAMP MEETS THE BLUE MAIN BODY. THE NURSE STATED THAT THE LEAK WAS ONLY NOTICEABLE WHEN SHE SHOOK THE TRANSFER SET. THE NURSE STATED THE HP NEVER FELT ANY WETNESS FROM THE LEAK. NEITHER THE PATIENT NOR NURSE KNEW WHAT COULD HAVE CAUSED THE LEAK. THE NURSE DID NOT NOTICE ANY ISSUES WHEN THE TRANSFER SET WAS ORIGINALLY PLACED ON THE HP. THE PATIENT STORES HER CATHETER IN A PD BELT, USES BETADINE AND ANOTHER UNSPECIFIED BRAND OF DISINFECTANT DURING THERAPY. IT WAS REPORTED THAT THE PATIENT DID NOT OVERTORQUE THE TWIST CLAMP AND DID NOT EXPERIENCE ANY PREVIOUS DIFFICULTY WHEN OPENING OR CLOSING THE TWIST CLAMP. THE PATIENT PERFORMS HER OWN THERAPY AND REPORTED THAT THE TRANSFER SET HAD NOT BEEN EXPOSED TO ANY EXCESSIVE FORCE AND NO DAMAGE TO THE SET WAS NOTICED. THE LOT NUMBER IS UNKNOWN, HOWEVER, THE SAMPLE IS AVAILABLE FOR EVALUATION. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ON 12/08/2010 FROM ONE OF THE PATIENT'S PERITONEAL DIALYSIS (PD) NURSES. THE PATIENT BEGAN AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY ON (B)(6) 2010 AND USES LOCAL PD2 AMBUFLEX, CONCENTRATION NOT SPECIFIED. THE PATIENT WAS DIAGNOSED WITH UNSPECIFIED PERITONITIS ON (B)(6) 2010. THE PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. THE NURSE INDICATED THE PATIENT'S GRAM STAIN WAS NEGATIVE. THE PATIENT WAS GIVEN A TWO WEEK COURSE OF ANTIBIOTICS (ANCEF AND CEPHAPIRIN) AND THE PATIENT CAME INTO THE PD CLINIC EVERY DAY (EXCEPT ON WEEKENDS) TO BE MONITORED DURING THE 2 WEEK ANTIBIOTIC THERAPY PERIOD. THE NURSE DESCRIBED THE PATIENT'S TRANSFER SET AS BEING THE SHORTER TYPE (DESCRIBED AS ABOUT 4 INCHES IN LENGTH) WITH A BLUE TWIST CLAMP. THE NURSE CLARIFIED THAT THE LEAK WAS ACTUALLY IDENTIFIED ON (B)(6) 2010 AND THE TRANSFER SET WAS CHANGED ON THAT DATE WHEN DURING THE ANTIBIOTIC THERAPY A LEAK WAS NOTED AS A SLIGHT DRIP AT THE JUNCTION OF THE TWO MOVEABLE COMPONENTS (WHERE THE WHITE TWIST CLAMP MEETS THE BLUE MAIN BODY). THE PD NURSE STATED THAT THE LEAKING TRANSFER SET WAS NOT NOTICED UNTIL AFTER THE PERITONITIS WAS DIAGNOSED . THE NURSE STATED THIS WAS BECAUSE THE LEAK WAS NOT OBVIOUS UNTIL IT WAS NOTED THAT A DRIP COULD BE CAUSED TO DROP OUT BY SHAKING THE TWIST CLAMP. THE NURSE HAS THE ACTUAL SAMPLE AND WILL RETURN UPON RECEIVING A RETURN KIT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention LOCAL PD2 AMBUFLEX