BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3790944 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14523
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896209, GD896290, AND GD896118 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CAUSE OF THIS ISSUE WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS RELATED TO A USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A USE ERROR THAT OCCURRED COINCIDENT WITH PD THERAPY. THE USE ERROR WAS FURTHER DESCRIBED AS THE PATIENT EXPERIENCED A REUSE OF SUPPLIES AND ACQUIRED A POSSIBLE PERITONITIS. FOUR DAYS PRIOR TO RECEIPT OF THIS REPORT, THE PATIENT REPORTED THAT THEY REUSED DISPOSABLES FURTHER DESCRIBED AS REUSED A MINICAP BECAUSE HE WAS¿ FRESH OUT OF STOCK¿. THE PD REGISTERED NURSE REPORTED THREE DAYS PRIOR TO RECEIPT OF THIS REPORT, THE PATIENT EXPERIENCED PERITONEAL CLOUDY EFFLUENT WITHOUT A DEFINITE DIAGNOSIS OF PERITONITIS. PER THE PD NURSE, THE CAUSE OF THE PERITONITIS WAS AN ¿ALLERGIC REACTION¿. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED PROPHYLACTICALLY FOR THE CLOUDY EFFLUENT WITH UNKNOWN ANTIBIOTICS (DOSE, ROUTE AND FREQUENCY NOT REPORTED). ON AN UNKNOWN DATE THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT THE PATIENT HAD RECOVERED FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267467 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention DIANEAL PD4 LOW CALCIUM 1.5%, EXTRANEAL SOLUTION