BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2013722 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-03014
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10F23064, H10H30032 AND H10I10065 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN 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 THIRD OF THREE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) REGARDING A PREVIOUS REPORT FROM A HOSPITAL NURSE THAT THE HOME PATIENT (HP) WAS HOSPITALIZED FOR PERITONITIS. THE PDRN STATED THAT ON (B)(6) 2011, THE HP SOUGHT EMERGENCY CARE AND WAS HOSPITALIZED UNTIL (B)(6) 2011 FOR UNSPECIFIED PERITONITIS. THE PD EFFLUENT WAS ANALYZED ON THE DATE OF ADMISSION. TREATMENT OF UNSPECIFIED INTRAPERITONEAL (IP) ANTIBIOTICS WAS THEN INITIATED. THE PDRN WAS NOT ABLE TO GIVE CAUSALITY, BUT STATED THAT THE BAXTER DIALYSIS DEVICES AND SOLUTIONS WERE NOT SUSPECT. THE HP HAS NOW RECOVERED AND CONTINUES WITH THE SAME PD THERAPY PRESCRIPTION.

    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 74 YR Hospitalization| R AMBUFLEXLOWCAL (PD4)| ULTRABAG LOWCAL (PD4)| HOME CHOICE CYCLER