BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19604750 · Received June 25, 2024

    Report

    Report Number
    3003442380-2024-10097
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    April 26, 2024
    Report Date
    October 24, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 6 OF 7. (B)(6).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 -(B)(4) - MDR 3003442380-2024-10097. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: THE COMPLAINT 1896262 HAS BEEN EVALUATED. THE BATCH 6003406 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS GUIDELINES FOR TEST OF REF. SAMPLES BUID-UMD VERSION 11 FOR THE CODE LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE) COMPLAINT INVESTIGATIONS: THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WORK INSTRUCTION VERSION 41 & WORK INSTRUCTION VERSION 18 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST ACCORDING TO WITH WORK INSTRUCTION VERSION 10 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE FLOW TEST. FUNCTIONAL TEST ACCORDING TO WITH WORK INSTRUCTION VERSION 25 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE LEAK TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6003406 ]WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 108 ON IN THE LINE INSET 6 ON 29/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. A QUERY WAS RUN IN TW AGAINST MALFUNCTION CODE LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6003406, NO OTHER COMPLAINT HAS BEEN REGISTERED IN THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED 7 INFUSION SET TUBING LEAKAGE EVENT ON 26-APR-2024. THE INFUSION SET WAS IN USE FOR 1-2 DAYS. THE LEAKAGE WAS AT CONNECTOR LOCATION. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208777 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6003406 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male