BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1950009 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00159
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10J13043, H10I24058 AND H10H29034 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE FIRST OF FIVE REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN, THEREFORE AN EVALUATION WAS NOT PERFORMED AND A BATCH REVIEW COULD NOT BE CONDUCTED. SHOULD A SAMPLE BE RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF FIVE REPORTS RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INITIALLY THE PATIENT CALLED FOR ASSISTANCE REGARDING A LOW DRAIN VOLUME ALARM. DURING THE CONVERSATION THE PATIENT REPORTED SHE HAD PERITONITIS. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    INITIALLY, THE PATIENT CALLED FOR ASSISTANCE REGARDING A LOW DRAIN VOLUME ALARM. DURING THE CONVERSATION, THE PATIENT REPORTED SHE HAD PERITONITIS. DURING A FOLLOW UP CALL ON (B)(6) 2011, THE FACILITY NURSE PROVIDED THE FOLLOWING INFORMATION: THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2010 AND INITIALLY TREATED ON AN OUTPATIENT BASIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 AND DISCHARGED ON (B)(6) 2010. THE PATIENT WAS INITIALLY STARTED ON INTRAVENOUS CEFTAZIDIME AND VANCOMYCIN (DOSES UNKNOWN) THEN SWITCHED TO CEFTAZIDIME AND VANCOMYCIN INTRAPERITONEAL (IP) DURING THE HOSPITALIZATION. THE PATIENT WAS DISCHARGED WITH ANCEF (DOSE UNKNOWN) FOR 14 DAYS. PERITONEAL DIALYSIS (PD) THERAPY CONTINUED DURING THE EVENT. THE CAUSE OF THE PERITONITIS IS UNKNOWN. THE PATIENT HAS RECOVERED FROM THE EVENT. THE NURSE INDICATED THAT THE PERITONEAL DIALYSIS SOLUTIONS OR DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT OF PERITONITIS. THE PATIENT IS CURRENTLY ON HEMODIALYSIS FOR AN UNRELATED ISSUE. THE NURSE DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%?| HOMECHOICE CYCLER