BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 11752509 · Received April 30, 2021

    Report

    Report Number
    1416980-2021-02543
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 25, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412476261
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H3: MANUFACTURER EVALUATED DEVICE WAS CHANGED FROM NO TO YES AND 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 (REMOVE C19) AND INVESTIGATION CONCLUSION (REMOVE D14). H10: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION (PREVIOUSLY ONLY A PHOTOGRAPH WAS RECEIVED FOR EVALUATION). A VISUAL INSPECTION OF THE SAMPLE WITH THE NAKED EYE NOTED THAT IN ADDITION TO THE DAMAGED MAIN BODY OF THE TRANSFER SET TWIST CLAMP, THE OCCLUDER LEGS FROM THE MAIN BODY WERE BROKEN. THEREFORE, THE REPORTED CONDITIONS OF DAMAGED MAIN BODY AND SEPARATION (DETACHMENT) BETWEEN THE MAIN BODY AND TWIST SLEEVE WERE VERIFIED (PREVIOUSLY REPORTED AS SEPARATION NOT VERIFIED). THE CAUSE OF THE REPORTED CONDITIONS COULD NOT BE DETERMINED; HOWEVER, THE CONDITIONS WERE CONSISTENT WITH DAMAGE CAUSED BY EXPOSURE TO CHEMICAL AGENTS SUCH AS FOREIGN SOLVENTS, DYES, OR CLEANING AGENTS THAT DAMAGE THE TRANSFER SET MATERIALS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: B4/F8: DATE OF THIS REPORT IN MDR FOLLOW UP #2 IS BEING CORRECTED FROM BLANK TO 06/07/2021.

    Additional Manufacturer Narrative · 0

    ADDITONAL INFORMATION IN H3, H6. H10: THE DEVICE WAS NOT RETURNED; HOWEVER A PHOTOGRAPH WAS PROVIDED FOR EVALUATION. A VISUAL INSPECTION OF THE PHOTOGRAPH NOTED A DAMAGED MAIN BODY. THE REPORTED DAMAGED MAIN BODY WAS VERIFIED. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED; HOWEVER, THE DAMAGE WAS CONSISTENT WITH DAMAGE CAUSED BY EXPOSURE TO CHEMICAL AGENTS SUCH AS FOREIGN SOLVENTS, DYES, OR CLEANING AGENTS THAT DAMAGE THE TRANSFER SET MATERIALS. THE REPORTED SEPARATION (DETACHMENT) BETWEEN THE MAIN BODY AND TWIST SLEEVE WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THESE CONDITIONS DURING THE MANUFACTURE OF THIS LOT. 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 THE MAIN BODY OF A MINICAP EXTENDED LIFE PD TRANSFER SET WAS DAMAGED; FURTHER DESCRIBED AS DAMAGE "WITH A SHARP OBJECT AND IN SMALL PIECES". IT WAS FURTHER REPORTED THAT THERE WAS A SEPARATION (DETACHMENT) BETWEEN THE WHITE TWIST SLEEVE AND MAIN BODY OF THE TRANSFER SET. THIS WAS NOTICED DURING PATIENT USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654269 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H20E13032 00085412476261

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR