BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1972700 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01184
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO USE ERROR - POOR ASEPTIC TECHNIQUE. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THIS DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED. THE ROOT CAUSE FOR THIS INCIDENT IS UNDETERMINED AT THIS TIME. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF DIZZINESS, TOUCH CONTAMINATION, AND PERITONITIS IN AN APPROXIMATELY (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED DIZZINESS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR THE DIZZINESS. IT WAS UNKNOWN IF A PERITONEAL EFFLUENT CULTURE WAS DONE. IT WAS UNKNOWN IF TREATMENT WAS PROVIDED FOR THE DIZZINESS. WHILE HOSPITALIZED, THE PATIENT DEVELOPED PERITONITIS. THE NURSE BELIEVED THAT THE PERITONITIS WAS CAUSED BY TOUCH CONTAMINATION. IT WAS UNKNOWN IF TREATMENT WAS PROVIDED FOR THE PERITONITIS. IT WAS UNREPORTED IF DIANEAL THERAPY WAS ONGOING. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERING FROM THE DIZZINESS, TOUCH CONTAMINATION, AND PERITONITIS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE DIZZINESS, TOUCH CONTAMINATION, AND PERITONITIS WERE UNRELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R HOMECHOICE CYCLER