BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3172630 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15531
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) THE HP CLARIFIED THE REPORT OF FUNGAL INFECTION WAS FUNGAL PERITONITIS (UNSPECIFIED). TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. FIVE DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE HP WAS DISCHARGED. THE HP STATED THAT HIS PERITONEAL DIALYSIS (PD) NURSE WAS INFORMED OF THE HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, THE HP WAS SWITCHED TO HEMODIALYSIS THERAPY. THE HP ALSO STATED THAT HIS DOCTOR STATED THAT HE PROBABLY WILL NOT GO BACK ON PD BECAUSE THERE WAS "SOME DAMAGE" DONE THAT MIGHT NOT ALLOW PD THERAPY (DETAILS NOT PROVIDED). AT THE TIME OF THIS REPORT HEMODIALYSIS WAS ONGOING. AT THE TIME OF THIS REPORT, THE HP WAS RECOVERING FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD894188 AND GD893891 WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. THERE IS FIELD CORRECTIVE ACTION, (B)(4), INITIATED ON BATCH GD893891. ONE UNUSED/UNOPENED MINICAP SAMPLE FROM LOT GD893891 WAS RECEIVED FOR EVALUATION BY BAXTER PRODUCT ANALYSIS LABORATORY (PAL). THE PATIENT STATED CONCERN OVER OPEN SEALS. VISUAL INSPECTION REVEALED THE SEAL AREA FOR THE SAMPLE WAS INTACT. PRESSURE TESTS WERE PERFORMED AND NO LEAKS WERE FOUND IN THE POUCH. NO FUNCTIONAL ISSUES WERE DETECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) WAS USING MINICAPS AND DEVELOPED A FUNGAL INFECTION DUE TO WHICH THE HP HAD TO GO TO THE HOSPITAL. THE HP DID NOT NOTICE ANY OPEN PACKAGING OR DEFECTS WITH THE MINICAPS PRIOR TO USE. THE HP STATED THAT THE CATHETER HAD TO BE REMOVED AND REPLACED. AS A RESULT, THE HP STARTED DOING HEMOTHERAPY INSTEAD OF PERITONEAL DIALYSIS THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272792 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893891

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R UNKNOWN CATHETER| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE| MINICAP TRANSFER SET