BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1822932 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03072
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 FOR ABDOMINAL PAIN AND ACUTE PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE AND ROUTE UNKNOWN). THE PATIENT HAD HER LAST TREATMENT OF PERITONEAL DIALYSIS (PD) THERAPY ON (B)(6) 2010. ON (B)(6) 2010, A CULTURE WAS TAKEN FROM THE PD CATHETER WHICH REVEALED STAPHYLOCOCCUS EPI. THE CATHETER WAS REMOVED THAT DATE. ON (B)(6) 2010 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT OUTCOME IS UNKNOWN. THE PATIENT IS CURRENTLY RECEIVING HEMODIALYSIS. THE PERITONITIS WAS REPORTEDLY NOT RELATED TOT HE DIANEAL SOLUTIONS. NO FURTHER INFORMATION WILL BE PROVIDED. THE OUTCOME OF HERNIA IS UNKNOWN, HOWEVER, THE PATIENT REPORTEDLY DID NOT HAVE SURGERY FOR REPAIR OF THE HERNIA. DURING A FOLLOW UP CALL, THE FACILITY NURSE PROVIDED THE FOLLOWING INFORMATION: THE ISSUE OF THE PATIENT'S PERITONITIS WAS DUE TO AN UNRELATED BOWEL PROBLEM. TOUCH CONTAMINATION WAS NOT AN ISSUE. THERE WAS NO ALLEGATION AGAINST ANY BAXTER DEVICE OR SOLUTION. THE PATIENT'S CATHETER HAD BEEN IN PLACE FOR FOUR YEARS AND THE MANUFACTURER WAS UNKNOWN. THE NURSE NO LONGER HAS THE PATIENT'S CHART AND WAS ABLE TO PROVIDE LIMITED INFORMATION REGARDING THE EVENT, OTHER THAN TO CONFIRM THE CATHETER WAS REMOVED AND THE PATIENT HAS TRANSFERRED TO A HEMODIALYSIS UNIT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAP DISCONNECT CAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 5B9766 1.5% LO/CAL UB 2L/2L DIANEAL 5B9770 1.5% LO