BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3944955 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23374
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER EVALUATION, IT WAS REPORTED THAT THE REPORTED PROBLEM WAS IDENTIFIED DURING THE VISUAL INSPECTION AS THE SPONGE WAS FOUND TO BE DRY. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 18 DEVICES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THAT EACH OF THESE DEVICES HAD BEEN OPENED. THE IODINE CONTENT OF (B)(4) OF THE 18 SAMPLES WAS EVALUATED AND FOUND TO MEET SPECIFICATION. (B)(4) RETENTION SAMPLES WERE THEN EVALUATED; EACH OF THESE SAMPLES PASSED SPLIT PRESSURE TESTING, AND EACH OF THESE SAMPLE'S SPONGES HAD ADEQUATE IODINE. THE REPORTED CONDITION WAS UNABLE TO BE VERIFIED NEITHER FOR THE OPEN SAMPLES NOR FOR THE RETENTION SAMPLES. A REVIEW OF ALL BATCH RECORD DOCUMENTS 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 WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPONGE OF A MINICAP WAS DRY. THIS WAS NOTED DURING USE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421375 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1039010

    Patients

    Seq Age Sex Outcome Treatment
    1