BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLUNG CATHETER KIT

    MDR report key: 6602727 · Received May 31, 2017

    Report

    Report Number
    3009763347-2017-00005
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    January 17, 2016
    Report Date
    May 31, 2017
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT, THERE ARE ON IDENTIFIED RADIATIONAL ACTIONS OR CORRECTIVE ACTIONS AS THE CONCLUSION FROM THE ANALYSIS AND PHYSICAL/NURSING STAFF THAT THE BREACH WAS MOST LIKELY CAUSED BY POSITIONING AND ANGEL OF THE CATHETER ON THE PATIENT AND NOT THE RESULT OF A FAILED DEVICE. THE INCIDENT REPORT WAS SUBMITTED TO (B)(6) AND CLOSED BY (B)(6) FOR (B)(4) AS AN EXPORTER.

    Description of Event or Problem · 1

    THIS IS AS A RESULT OF THE FDA (B)(6). THE SUMMARY OF THE FINAL REPORT ARE ATTACHED AND PROVIDED BELOW: A BREACH IN THE OUTER CANNULA WAS OBSERVED BETWEEN THE BIFURCATION AND THE CATHETER BEND. THE BREACH FOLLOWED THE WIRE REINFORCEMENT WIRE, AND EXTENDED APPROXIMATELY 50% AROUND THE CIRCUMFERENCE OF THE OUTER CANNULA. A CONFERENCE CALL WAS HELD WITH THE CATHETER MANUFACTURER (AVALON LABORATORIES, LLC) TO DISCUSS THIS CASE ON MARCH 1, 2016. ACCORDING TO THEIR QUALITY TEAM, THE TYPE OF BREACH OBSERVED IN THIS CASE USUALLY ONLY OCCURS WHEN SUTURES ARE PLACED DIRECTLY ON THE CANNULA BODY. WHILE THERE WAS NO EVIDENCE OF A SUTURE AT THE BREACH, IT WAS CONSISTENT IN APPEARANCE AND LOCATION WITH PREVIOUS CASES INVOLVING SUTURES PLACED DIRECTLY ON THE CATHETER BODY (CASES (B)(4)). INFORMATION PROVIDED FROM THE TREATING PHYSICIAN DOES NOT INDICATE THAT A SUTURE WAS PLACED DIRECTLY ON THE CANNULA BODY. THE PHYSICIAN NOTED A "KINK" OR STRESS ON THE CATHETER DUE TO PATIENT AND DEVICE PLACEMENT PRIOR TO THE BREACH. MECHANICAL FAILURE CANNOT BE RULED OUT, ALTHOUGH THE HEMOLUNG CATHETERS WERE SUCCESSFULLY TESTED FOR KINK RESISTANCE AND PULL-TO-BREAK TESTING IN ACCORDANCE WITH ISO 10555-1 INTRAVASCULAR CATHETERS -- STERILE AND SINGLE-USE CATHETERS -- PART 1: GENERAL REQUIREMENTS. FEEDBACK FROM THE CATHETER MANUFACTURER INDICATED SUTURES WERE THE MOST LIKELY CAUSE OF FAILURE, BUT INFORMATION FROM THE USER DID NOT SUPPORT THIS THEORY. ALTERNATIVELY, KINKING/STRESSING DURING USE WAS INDICATED AS THE MOST LIKELY CAUSE BY THE USER, BUT IS NOT SUPPORTED BY MECHANICAL BENCH TESTING. IN THE ABSENCE OF ANY FURTHER EVIDENCE, NEITHER CAUSE CAN BE SUPPORTED OR RULED OUT. AT THIS TIME NO DEFINITIVE CONCLUSION CAN BE MADE. THE FINAL REPORT WAS SUBMITTED TO (B)(6) AND CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381544 HEMOLUNG CATHETER KIT HEMOLUNG CATHETER KIT DQR ALUNG TECHNOLOGIES, INC. REF 30100

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other