BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2163095 · Received July 15, 2011

    Report

    Report Number
    1423500-2011-09056
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBER (H11C23102) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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 FIFTH OF FIVE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) REGARDING A RELATED ISSUE OF THE HP NOT FEELING WELL. THE PDRN STATED THAT THE HP HAD PERITONITIS AND WAS HOSPITALIZED FROM (B)(6) 2011- (B)(6) 2011. CULTURES WERE OBTAINED ON (B)(6) 2011. TREATMENT INITIATED WHILE HOSPITALIZED WAS WITH INTRAPERITONEAL (IP) VANCOMYCIN 3 TIMES WKLY AND IP CEFTAZIDIME DAILY, BOTH 1 GM DOSES. THE HP RECEIVED THE LAST IP DOSE OF ANTIBIOTICS ON (B)(6) 2011. CAUSALITY WAS GIVEN AS AN UNTRAINED CAREGIVER ASSISTING THE HP WITH PD THERAPY. THE HP'S RECOVERY IS ONGOING AND IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R LOWCAL (PD4) AMBUFLEX| HOME CHOICE CYCLER