BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 12233664 · Received July 27, 2021

    Report

    Report Number
    1416980-2021-04615
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 30, 2021
    Report Date
    September 28, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, D9, G4, H3, H6 AND H10. D4: CATALOGUE #: FROM 5C4482 TO 5C4483. G4: PMA/510K # OR BLA #: FROM K152675 TO K192705. H3: DEVICE RETURNED FOR EVALUATION WAS CHANGED FROM NO TO YES. H6: TYPE OF INVESTIGATION WAS UPDATED TO INCLUDE B01 FOR THE ACTUAL SAMPLE RECEIVED. INVESTIGATION FINDINGS WAS CHANGE FROM C20 TO C13. H10: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION WITH A CAP ON THE DARK BLUE CONNECTOR AND THE WHITE TWIST CLAMP WAS IN CLOSED POSITION. A VISUAL INSPECTION OF THE SAMPLE WITH THE NAKED EYE AND MAGNIFICATION NOTED A BROKEN OCCLUDE FOOT. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED; LEAK TESTING AND CLAMP FUNCTION TESTING IDENTIFIED A LEAKAGE THROUGH THE TRANSFER SET WITH THE TWIST CLAMP CLOSED. NO ISSUES WERE OBSERVED DURING CLAMP FUNCTION TESTING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE SEPARATION WAS DUE TO THE BROKEN OCCLUDE FOOT, HOWEVER THE CAUSE OF THE BROKEN OCCLUDE FOOT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE LIGHT BLUE MAIN BODY AND THE WHITE TWIST SLEEVE OF THE TWIST CLAMP ON A MINICAP EXTENDED LIFE PD TRANSFER SET. THIS WAS FURTHER DESCRIBED AS ¿THE CLAMP (WHITE TWIST SLEEVE) COMPLETELY UNSCREWED¿. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY WHILE THE HOME PATIENT'S (HP) CAREGIVER WAS WAITING TO DOCUMENT THE INITIAL DRAIN. THE TRANSFER SET HAD BEEN IN USE FOR SIX (6) MONTHS. THE HP WAS GIVEN PROPHYLACTIC ANTIBIOTICS (VANCOMYCIN AND CEFEPIME X THREE (3) DAYS OVERNIGHT) AS A PRECAUTIONARY MEASURE. ADDITIONALLY, THE CLINIC DREW A SAMPLE OF THE HP¿S PERITONEAL FLUID (EFFLUENT) FOR A CELL COUNT AND CULTURE AND THE RESULTS WERE NEGATIVE FOR PERITONITIS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131347 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO TITANIUM ADAPTER.| TITANIUM ADAPTER