BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 9362164 · Received November 22, 2019

    Report

    Report Number
    1018233-2019-07488
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Report Date
    February 3, 2020
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE COULD BE A FAULTY LOAD CELL. HOWEVER, THIS CANNOT BE CONFIRMED. THE SERIAL NUMBER FOR THE DEVICE ASSOCIATED WITH THIS PARTICULAR EVENT COULD NOT BE IDENTIFIED BY THE COMPLAINANT; HOWEVER, THE FOLLOWING SERIAL NUMBERS (B)(4), DATE OF MANUFACTURE 09/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 08/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 09/01/218; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 09/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 08/01/2018; (B)(4), DATE OF MANUFACTURE 09/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 08/01/2018; (B)(4), DATE OF MANUFACTURE 09/01/2018; (B)(4), DATE OF MANUFACTURE 09/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 08/01/2018; (B)(4), DATE OF MANUFACTURE 10/01/2018; (B)(4), DATE OF MANUFACTURE 09/01/2018; (B)(4), DATE OF MANUFACTURE 04/01/2018; (B)(4), DATE OF MANUFACTURE 03/01/2018 WERE IN USE AT THE TIME THIS EVENT OCCURRED. THESE SERIAL NUMBERS UNDERWENT A MANUFACTURING REVIEW AND THE DEVICE HISTORY RECORDS FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "THE SYSTEM SOFTWARE IS DESIGNED TO CALIBRATE EACH TIME A NEW RING IS ATTACHED TO ENSURE ACCURATE CALCULATIONS OF URINE OUTPUT VOLUME. THE SENSICA UO SYSTEM FOR ICU IS DESIGNED TO BE USED WITH ANY FOLEY CATHETER CONNECTED TO ANY STANDARD URINE DRAINAGE BAG, WITH OR WITHOUT A URINE METER. DO NOT USE THE SENSICA UO SYSTEM WITH SPECIALTY DISPOSABLES DESIGNED FOR EXCLUSIVE USE WITH OTHER ELECTRONIC URINE OUTPUT MONITORS, SUCH AS THE BARD CRITICORE OR PROTRERO ACCURYN MONITORING SYSTEMS. USE OF THE SENSICA UO SYSTEM WITH SPECIALTY DISPOSABLE URINE COLLECTION SYSTEMS WILL LIKELY YIELD INACCURATE UO MEASUREMENTS." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT ACCURATELY MEASURING THE URINE OUTPUT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT ACCURATELY MEASURING THE URINE OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160873 SENSICA UO MONITOR ICU SENSICA DEVICE EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1