BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2003956 · Received March 1, 2011

    Report

    Report Number
    1423500-2011-02587
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10H31055 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE FOR THE PERITONITIS IS THE PATIENT'S MEDICAL CONDITION, UPPER RESPIRATORY INFECTION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BAXTER CONTACTED A NURSE (RN) (B)(6) 2011 REGARDING A RECENT REPORT OF THE HOME PATIENT (HP) BEING HOSPITALIZED. THE RN STATED THAT THE HP HAD PERITONITIS. ON (B)(6) 2011, BAXTER SPOKE WITH THE CAREGIVER (CG) FOR THE HP WHO STATED THAT THE HP HAD AN ONSET OF ABDOMINAL PAIN AND NAUSEA THE EVE OF (B)(6) 2011 AND SOUGHT EMERGENCY CARE. SHE WAS ADMITTED TO THE HOSPITAL, CULTURED THAT NIGHT AND TREATED FOR BACTERIAL PERITONITIS. ON (B)(6) 2011, THE HP WAS DISCHARGED HOME. TREATMENT HAD BEEN ONGOING INTRAPERITONEALLY (IP) FROM (B)(6) 2011 UNTIL (B)(6) 2011. THE CG COULD NOT GIVE A CAUSALITY STATEMENT, BUT STATED THAT THE DOCTOR THOUGHT THE HP'S RECENT UPPER RESPIRATORY INFECTION COULD BE THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R LOCAL (PD4) AMBUFLEX| HOME CHOICE CYCLER