BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME PD SYSTEM KAGUYA SET

    MDR report key: 10906672 · Received November 25, 2020

    Report

    Report Number
    1416980-2020-07378
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 30, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, H3 AND H6. CORRECTION: B5, G4 AND F10/H6. B5: AFTER SHUT DOWN OF THE DEVICE DURING TROUBLESHOOTING, WHEN THE CASSETTE WAS REMOVED, IT WAS NOTED THAT THE HEATER BAG TUBE WAS DETACHED (OFF) FROM THE CASSETTE (CLARIFICATION OF EVENT OMITTED ON INITIAL). G4 DATE: REPLACE (B)(6) 2020 WITH (B)(6) 2020. F10/H6: DEVICE CODES: ADD 1171, 553 AND 525. H10: ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION WITHOUT POUCH. A VISUAL INSPECTION NOTED THE HEATER BAG LINE WAS SEPARATED FROM THE WELDED CASSETTE SUB-ASSEMBLY. THE HEATER LINE'S PORT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN SPECIFICATION. SOLVENT RESIDUE WAS PRESENT IN THE TUBING AND THE TUBING SHAPE SHOWED THE TUBING HAD BEEN FULLY INSERTED INTO THE PORT. THEREFORE, IT WAS DETERMINED THERE WAS NO ISSUE RELATED TO THE MANUFACTURING PROCESS. AN UNDERWATER PRESSURE TEST WAS ALSO PERFORMED WITH NO ISSUES NOTED. 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 · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOW PRIORITY 30166 (MAX AIR EXCEEDED) ALARM OCCURRED ON A HOME PD SYSTEM KAGUYA CYCLER DURING PERITONEAL DIALYSIS (PD) THERAPY. THIS ALARM OCCURRED DURING USE WHILE THE PATIENT WAS CONNECTED. DURING TROUBLESHOOTING, IT WAS REPORTED THAT A LEAK WAS OBSERVED AROUND THE FRONT DOOR AREA OF THE PD CYCLER. THE LEAKAGE WAS FOUND WHEN THE HOME PD SYSTEM KAGUYA SET (CASSETTE) WAS REMOVED AND THE HEATER BAG WAS OFF, HOWEVER, THE HEATER BAG ITSELF WAS NOT LEAKING. RENAL THERAPY SERVICES (RTS) ASSISTED THE NURSE WITH CLEARING THE ALARM. 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
    1371670 HOME PD SYSTEM KAGUYA SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 KAGUYA PD CYCLER| UNSPECIFIED PD SOLUTION