BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1831994 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03341
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS IS NUMBER 2 OF 4 COMPLAINTS REPORTED FOR THIS PERITONITIS

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBERS (GD874834 AND GD873919), WITH NO DEFECTS NOTED. THE ASSIGNABLE CAUSE OF THE REPORTED PROBLEM OF PERITONITIS WAS USE ERROR - POOR AESEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WAS CURRENTLY GETTING OVER A CASE OF PERITONITIS. THE NURSE CLARIFIED THAT THIS WAS A RECURRING PERITONITIS. PER THE NURSE, THE SUSPECTED CAUSE IS TOUCH CONTAMINATION AND THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. DUE TO THE PATIENT BEING TRANSFERRED TO IN-CENTER HEMODIALYSIS, LIMITED INFORMATION REGARDING THE REPORTED PERITONITIS WAS AVAILABLE. DURING THE WEEK OF (B)(6) 2010, THE PATIENT PRESENTED WITH CLOUDY EFFLUENT AND ABDOMINAL PAIN AND WAS HOSPITALIZED FOR THE RECURRING PERITONITIS. THE PATIENT'S CATHETER WAS REMOVED AND HE STARTED IN CENTER HEMODIALYSIS ON (B)(6) 2010. THE PATIENT WAS TREATED WITH ANTIBIOTIC (UNKNOWN) AND RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R