BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2950976 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03362
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 16, 2013
    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)(40. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING RECORDS WERE REVIEWED FOR POTENTIALLY ASSOCIATED LOTS 12G18H25 AND 12H24H25 AND THERE WERE NO ISSUES DETECTED DURING THE PRODUCTION OF THESE BATCHES RELATING TO THE NATURE OF THIS COMPLAINT. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A NURSE IN THE USA OF PERITONITIS WHICH OCCURRED IN A HOME PATIENT (HP) ON PERITONEAL DIALYSIS (PD) THERAPY. THE HP PERFORMS PD THERAPY WITH DIANEAL PD2 AMBUFLEX (12 LITERS NIGHTLY), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). RECENTLY, EXTRANEAL VIAFLEX (2 LITERS NIGHTLY), IP, WAS ADDED TO THE PATIENT'S PD THERAPY. THE NURSE REPORTED THE PATIENT HAD BACTERIAL PERITONITIS MANIFESTED BY ABDOMINAL PAIN. THE PATIENT WAS TREATED FOR THE PERITONITIS WITH ANCEF AND FORTAZ FOR 7 DAYS (DOSES, FREQUENCIES, AND LOTS NOT REPORTED). DURING THIS TIME, THE PATIENT REPORTED ALSO HAVING HAND PAIN WITH THE SKIN ON THE PALMS OF HIS HANDS BEING DRY AND FLAKING OFF (FLAKING SKIN TO BILATERAL PALMS AND BILATERAL HAND PAIN). TREATMENT WITH THE ANCEF AND FORTAZ WAS ENDED. NEW TREATMENT FOR THE PERITONITIS WAS INITIATED WITH TOBRAMYCIN, 40MG, IP, DAILY, TO CONTINUE FOR 14 DAYS TOTAL AND ORAL CIPRO, 500MG, DAILY (LENGTH OF TREATMENT NOT REPORTED). THERAPY WITH EXTRANEAL WAS TEMPORARILY STOPPED DUE TO THE HAND PAIN AND FLAKING SKIN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS AND DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE EVENTS OF HAND PAIN, SKIN ON THE PALMS OF HANDS DRY AND FLAKING OFF HAD RESOLVED. EXTRANEAL WAS RESTARTED WITH NO FURTHER ISSUES. THE NURSE REPORTED THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE NURSE REPORTED THE PATIENT WAS COUNSELED ON PROPER ASEPTIC TECHNIQUE; HOWEVER, THE PATIENT HAD NOT YET HAD FORMAL RE-TRAINING. THE NURSE REPORTED THE PERITONITIS, HAND PAIN, AND SKIN ON THE PALMS OF HANDS DRY AND FLAKING OFF, WERE NOT RELATED TO A BAXTER DEVICE OR SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54764 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention EXTRANEAL VIAFLEX| DIANEAL PD2 AMBUFLEX