BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUILEX FLUID CONTROL SYSTEM

    MDR report key: 9822719 · Received March 12, 2020

    Report

    Report Number
    3002914049-2020-00003
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 11, 2020
    Report Date
    August 13, 2020
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HIG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE TWO VARIANTS OF THE AQUILEX FLUID CONTROL SYSTEM HAVE BEEN CLEARED BY FDA (K112642 OR K172040). AS NO SERIAL NUMBER OR REF NUMBERS WERE PROVIDED BY THE COMPLAINANT, IT IS UNKNOWN WHICH VARIANT IS AFFECTED. NO FURTHER INFORMATION WAS PROVIDED BY THE COMPLAINANT AND THE DEVICE WAS NOT RETURNED. THE MANUFACTURER CLOSED THIS CASE.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "CALLED AT 9:17AM TO HELP TROUBLESHOOT REGARDING FLUID DEFICIT READING. WALKED DOCTOR AND STAFF THROUGH THE FOLLOWING SUGGESTIONS: ASSESS IF THERE WAS POSSIBLE PERFORATION OR LEAKAGE. ASSESS IF ANY FLUID HAS ACCUMULATED ON THE GROUND OR IF FLUID HAS BEEN COLLECTED UNDERNEATH THE DRAPES UNDER THE PATIENT. ASSESS IF THERE WERE ANY KINKS OR TWISTS IN THE INFLOW TUBING, WHERE THE TUBING WAS SPIKED INTO THE BAG AND WHERE THE TUBING WAS WRAPPED AROUND THE PUMP. ASKED IF AT ANY POINT DID THE FLUID SUPPLY BAG RUN DRY? ASSESS FLUID AMOUNT FROM IN'S AND OUT'S (MANUAL COUNT). AFTER MANUAL COUNT- THE TEAM DECIDED TO ABORT THE PROCEDURE. TO MY BEST KNOWLEDGE THERE IS NO KNOWN PATIENT INJURY.":

    Additional Manufacturer Narrative · 1

    THERE ARE TWO VARIANTS OF THE AQUILEX FLUID CONTROL SYSTEM HAVE BEEN CLEARED BY FDA (K112642 OR K172040). AS NO SERIAL NUMBER OR REF NUMBERS WERE PROVIDED BY THE COMPLAINANT, IT IS UNKNOWN WHICH VARIANT IS AFFECTED. THE DESCRIPTION OF THE COMPLAINT SITUATION IS VERY SPARSE, AND THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION UNTIL TODAY. FURTHER ATTEMPTS WILL BE MADE TO OBTAIN MORE INFORMATION ABOUT THE COMPLAINT SITUATION, AND TO RETRIEVE THE DEVICE FROM THE COMPLAINANT. A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: CALLED AT 9:17AM TO HELP TROUBLESHOOT REGARDING FLUID DEFICIT READING. WALKED DOCTOR AND STAFF THROUGH THE FOLLOWING SUGGESTIONS: ASSESS IF THERE WAS POSSIBLE PERFORATION OR LEAKAGE. ASSESS IF ANY FLUID HAS ACCUMULATED ON THE GROUND OR IF FLUID HAS BEEN COLLECTED UNDERNEATH THE DRAPES UNDER THE PATIENT. ASSESS IF THERE WERE ANY KINKS OR TWISTS IN THE INFLOW TUBING, WHERE THE TUBING WAS SPIKED INTO THE BAG AND WHERE THE TUBING WAS WRAPPED AROUND THE PUMP. ASKED IF AT ANY POINT DID THE FLUID SUPPLY BAG RUN DRY? ASSESS FLUID AMOUNT FROM IN'S AND OUT'S (MANUAL COUNT). AFTER MANUAL COUNT THE TEAM DECIDED TO ABORT THE PROCEDURE. TO MY BEST KNOWLEDGE, THERE IS NO KNOWN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291020 AQUILEX FLUID CONTROL SYSTEM HYSTEROSCOPY PUMP AND SCALE HIG W.O.M. WORLD OF MEDICINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1