BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1903730 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06034
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THIS IS REPORT 4 OF 6 FOR THIS PERITONITIS EPISODE.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT (10F15H25) 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

    DURING FOLLOW-UP FOR AN UNRELATED ISSUE, THE PATIENT'S NURSE INDICATED THE PATIENT WAS BEING TREATED FOR PERITONITIS. THE NURSE STATED THE PATIENT NEEDED TO HAVE ANOTHER DOSE OF ANTIBIOTICS AND WAS CONTINUING WITH THERAPY. THE NURSE STATED THE PATIENT HAS NOT REPORTED ANY SYMPTOMS. THE NURSE STATED THE PATIENT WAS DOING WELL WITH THE FOLLOWING TREATMENTS. THE NURSE THEN STATED SHE DID NOT WANT TO BE CONTACTED ABOUT THE PATIENT AND NO OTHER INFORMATION WOULD BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF ONE (1) INFUSOR TWO DAY DEVICE HAD RUPTURED DURING FILLING. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL (5-FU). THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention