BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 11901326 · Received May 28, 2021

    Report

    Report Number
    1416980-2021-03216
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3, H6 (ADD B01). DURING EVALUATION, DEVICE INFORMATION WAS OBTAINED. D1: BRAND NAME OF MINICAP TRANSFER SET, D4 CATALOGUE # OF 5C4483, AND A G4: PMA/510K # OF K192705. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION USING THE NAKED EYE FOUND THE PATIENT CONNECTOR ATTACHED TO THE TUBING/BUSHING; HOWEVER, THE PATIENT CONNECTOR WAS SLIPPED BACK INDICATING THE CONNECTOR WAS POSITIONED FOR SHIPPING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE PHOTOGRAPH WAS VISUALLY INSPECTED AND THE PATIENT CONNECTOR SEPARATED FROM THE TUBING WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THE ASSEMBLY BETWEEN THE PATIENT CONNECTOR AND THE TUBING IS A FRICTION FIT AND NOT A SOLVENT BOND. A STRONG TUG ON THE CONNECTOR OR TUBING COULD CAUSE THE SEPARATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONNECTOR OF A PERITONEAL DIALYSIS (PD) TRANSFER SET SEPARATED FROM THE TUBING. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿THE PATIENTS TRANSFER SET FELL OFF¿. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF 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
    797616 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1