BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2061180 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04642
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION AS IT HAD BEEN DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR UPON THE COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) - A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H10K17067, H11A24096, H11A01490 AND H10L21067 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    BAXTER SPOKE TO THE CAREGIVER (CG) ON (B)(6) 2011 REGARDING A RELATED SYSTEM ERROR ALARM OCCURRING ON (B)(6) 2011. THE CG STATED THAT NO AIR WAS NOTED IN THE LINE THE NIGHT OF THE EVENT, BUT THAT THE HP HAD SINCE DEVELOPED PERITONITIS. BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) ON (B)(6) 2011 FOR FOLLOW UP WHO STATED THAT ON (B)(6) 2011 THE CG BROUGHT PERITONEAL DIALYSIS (PD) EFFLUENT INTO THE CLINIC FOR ANALYSIS AS THE HP WAS TOO ILL TO COME FOR A CLINIC APPOINTMENT. THE HP HAD ONSET OF ABDOMINAL PAIN AND VOMITING THAT DAY WITH CLOUDY PD EFFLUENT. INTRAPERITONEAL (IP) LOADING DOSES OF VANCOMYCIN 2GM AND FORTAZ 1GM WERE INITIATED ON (B)(6) 2011, THEN WITH IP VANCOMYCIN 1GM EVERY 5 DAYS FOR 21DAYS AND IP FORTAZ 1GM DAILY FOR 3 DAYS. AT THE TIME OF THIS REPORT, THE PDRN STATED THAT THE HP HAD NOT YET RECOVERED. THE PD EFFLUENT WAS STILL CLOUDY AND THE HP WAS STILL EXHIBITING SYMPTOMS. THE PDRN STATED THAT THE HP WAS DUE FOR SCHEDULED CLINIC ON (B)(6) 2011 WHEN THE HP AND HIS TREATMENT WOULD BE RE-EVALUATED. THE PDRN STATED CAUSALITY WAS NOT RELATED TO ASEPTIC TECHNIQUE AS THE CG HAD BEEN PERFORMING PD THERAPY FOR THE HP FOR YEARS AND EXHIBITED METICULOUS TECHNIQUE. THE PDRN DID NOT KNOW IF THE BAXTER PRODUCTS WERE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCAL (PD4) AMBUFLEX| HOME CHOICE CYCLER