BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2132800 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07776
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF FIVE REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER 11A19H25 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH NCR (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER RECEIVED A CALL FROM THE HOME PATIENT (HP) WHO REPORTED THAT SHE HAD AN INFECTION AND WAS RECEIVING TREATMENT. ON (B)(6) 2011, BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) WHO STATED THAT THE HP HAD PERITONITIS WITH SYMPTOM ONSET (B)(6) 2011 OF ABDOMINAL PAIN. ON (B)(6) 2011 PERITONEAL DIALYSIS (PD) EFFLUENT WAS OBTAINED AND TREATMENT PER PROTOCOL WAS INITIATED WITH SINGLE INTRAPERITONEAL (IP) DOSES OF CEFAZOLIN 1GM AND GENTAMICIN 40MG. AFTER CULTURES RESULTED, VANCOMYCIN 2GM IP EVERY 3 DAYS FOR 6 DOSES WAS GIVEN. THE OUTCOME IS ONGOING AND IMPROVED. PD EFFLUENT WILL BE RECULTURED ON OR ABOUT (B)(6) 2011. THE PDRN COULD NOT GIVE CAUSALITY, BUT STATED THAT THE BAXTER PD PRODUCTS WERE NOT RELATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention LOCAL(PD4)AMBUFLEX| HOMECHOICE| LOCAL(PD4)ULTRABAG