BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 21834508 · Received April 14, 2025

    Report

    Report Number
    1416980-2025-02110
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    February 15, 2025
    Report Date
    May 15, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    UDI-DI
    00854126102380
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D4: LOT #: 09FLHC (PREVIOUSLY SUBMITTED AS 01GAHC). CORRECTION MADE TO D4: EXPIRATION DATE: 12/02/2029 (PREVIOUSLY SUBMITTED AS 01/02/2030). CORRECTION MADE TO D4: UNIQUE IDENTIFIER (UDI) #: (B)(4) [PREVIOUSLY SUBMITTED AS (B)(4)]. CORRECTION MADE TO H4: DEVICE MANUFACTURE DATE: 12/30/2024 (PREVIOUSLY SUBMITTED AS 01/31/2025). ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6 AND H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WAS NO PARTICLE WAS IDENTIFIED IN THE CASSETTE NOR IN ANY OTHER COMPONENT OF THE EQUIPMENT. VISUAL INSPECTION OF TWELVE (12) RETENTION SAMPLES DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) WITHIN A HOMECHOICE AUTOMATED PD SET WITH CASSETTE. THE PM WAS FURTHER DESCRIBED AS THE CASSETTE HAS ¿TRASH (FOREIGN OBJECT) INSIDE¿. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICE FOR 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
    1022785 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ VANTIVE US HEALTHCARE LLC NA 09FLHC 00854126102380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DIANEAL 1.5%, PD-2