BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTEM SIGMA SYSTEM

    MDR report key: 18161301 · Received November 17, 2023

    Report

    Report Number
    3005792925-2023-00001
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 18, 2023
    Report Date
    December 19, 2023
    Manufacturer
    TEM INNOVATIONS GMBH
    Product Code
    JPA
    UDI-DI
    04260160470372
    PMA / PMN Number
    K201440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY RESULTS OF THE INVESTIGATION SHOWED NO OBVIOUS ERROR FOR THE ROTEM SIGMA INSTRUMENT AND REAGENTS CHECKED BY QC CARTRIDGE, QC TEST AND A NORMAL PATIENT SAMPLE. DRAW BLOOD ERROR IS DISPLAYED AFTER BLOOD IS DRAWN INTO THE CARTRIDGE. CUSTOMER REPORTED NO VISUAL PROBLEMS WITH THE TUBE. A SAMPLE WAS CAREFULLY RE-DRAWN, AGAIN NO VISUAL PROBLEMS WITH THE TUBE OR UNDERFILLING. REVIEW OF THE LOG FILE INDICATED THAT THE INSTRUMENT IDENTIFIED A BUBBLE IN THE SAMPLE. INVESTIGATION IS ON-GOING. FOLLOWING INVESTIGATION WAS INITIATED WITH THE CUSTOMER: 1) CHECK OF THE PERFORMANCE OF CARTRIDGE LOTS USED FOR ALL SAMPLES INCLUDING THE CRITICAL PATIENT SAMPLE ON DATE OF OCCURRENCE. 2) CHECK OF THE PERFORMANCE OF THE ROTEM SIGMA SYSTEM BY REVIEWING THE MAINTENANCE HISTORY. 3) THE CUSTOMER WAS CONTACTED TO OBTAIN MORE INFORMATION ABOUT THE SAMPLES ANALYZED AND THE BLOOD COLLECTION SYSTEM FOR THIS CRITICAL PATIENT SAMPLE FOR WHICH THE SYSTEM BLOOD ERROR OCCURRED. 4) CONSULTATION WITH THE MEDICAL DIRECTOR. THE FAILURE TO OBTAIN A ROTEM READING DID NOT CAUSE OR CONTRIBUTE TO INJURY DUE TO THE GARBAGE TRUCK ACCIDENT AND SUBSEQUENT DEATH, ACCORDING TO THE TREATING PHYSICIAN. A CROSS-FUNCTIONAL TEAM INVESTIGATED THE COMPLAINT TO IDENTIFY ITS ROOT CAUSE. THE INSTRUMENT, THE CARTRIDGE AND THE SAMPLE HAVE BEEN INVESTIGATED FOR CONTRIBUTION TO THE FAILURE MODE. THE INVESTIGATION OF THE ROTEM SIGMA INSTRUMENT (SERIAL NUMBER 10248) REVEALED THAT FOR BOTH MEASUREMENTS, THE OPTICAL IN PROCESS CONTROL DETECTED A DISCONTINUITY IN THE SAMPLE FLOW. THE INVESTIGATION OF THE CARTRIDGE LOT (S230402) REPORTED IN THE COMPLAINT SHOWED THAT ALL IN-PROCESS CONTROLS WERE PERFORMED AND THAT SPECIFICATIONS HAVE BEEN MET. TOOLS USED FOR THE IN-PROCESS CONTROLS HAVE BEEN VERIFIED FOR THEIR SUCCESSFUL MAINTENANCE. BASED ON THE REVIEWED INFORMATION, NEITHER THE ROTEM SIGMA INSTRUMENT NOR THE CARTRIDGE CONTRIBUTED TO THE FAILURE MODE. THE INVESTIGATION OF THE SAMPLE REVEALED THAT A DRAW TECHNIQUE HAD TO BE USED BY THE USER TO RETRIEVE A SAMPLE FROM THE PATIENT WHICH IS OUTSIDE OF THE SAMPLE COLLECTION TUBES INTENDED USE. THE USED DRAW METHOD LED TO UNINTENDED WASTE OF SAMPLE VOLUME DURING THE ATTACHMENT OF THE TUBE TO THE CARTRIDGE, AND THEREFORE LED TO INSUFFICIENT SAMPLE VOLUME FOR THE ROTEM MEASUREMENT. THE ROTEM SIGMA CORRECTLY DETECTED A DISCONTINUITY IN THE SAMPLE FLOW. RESULTS OF THE INVESTIGATION INDICATED THAT THE DEVICE PERFORMED ACCORDING TO ITS INTENDED USE.

    Additional Manufacturer Narrative · 0

    PRELIMINARY RESULTS OF THE INVESTIGATION: 1) REVIEW OF HOSPITAL TRANSFUSION PROTOCOL (ASK FOR ENGLISH TRANSFUSION PROTOCOL). 2) REVIEW OF ERROR DESCRIPTION DRAW_BLOOD_2. 3) LIQUID QC CONTROLS PASSED. 4) SAMPLE OF NORMAL PATIENT WITH NO ERROR (CLARIFICATION REQUESTED ABOUT USED SAMPLE). 5) SYSTEM WAS CHECKED WITH SYSTEM QC CARTRIDGE, NO ERROR OCCURRED. THIS INFORMATION SHOWS NO OBVIOUS ERROR FOR THE ROTEM SIGMA INSTRUMENT AND REAGENTS CHECKED BY QC CARTRIDGE, QC TEST AND A NORMAL PATIENT SAMPLE. DRAW BLOOD ERROR IS DISPLAYED AFTER BLOOD IS DRAWN INTO THE CARTRIDGE. CUSTOMER REPORTED NO VISUAL PROBLEMS WITH THE TUBE. A SAMPLE WAS CAREFULLY RE-DRAWN, AGAIN NO VISUAL PROBLEMS WITH THE TUBE OR UNDERFILLING. REVIEW OF THE LOG FILE INDICATED THAT THE INSTRUMENT IDENTIFIED A BUBBLE IN THE SAMPLE. INVESTIGATION IS ON-GOING. FOLLOWING INVESTIGATION WAS INITIATED WITH THE CUSTOMER (INVESTIGATION IS IN PROGRESS AT DATE OF REPORTING): 1) CHECK OF THE PERFORMANCE OF CARTRIDGE LOTS USED FOR ALL SAMPLES INCLUDING THE CRITICAL PATIENT SAMPLE ON DATE OF OCCURRENCE. 2) CHECK OF THE PERFORMANCE OF THE ROTEM SIGMA SYSTEM BY REVIEWING THE MAINTENANCE HISTORY. 3) THE CUSTOMER WAS CONTACTED TO OBTAIN MORE INFORMATION ABOUT THE SAMPLES ANALYZED AND THE BLOOD COLLECTION SYSTEM FOR THIS CRITICAL PATIENT SAMPLE FOR WHICH THE SYSTEM BLOOD ERROR OCCURRED. 4) CONSULTATION WITH THE MEDICAL DIRECTOR. THE FAILURE TO OBTAIN A ROTEM READING DID NOT CAUSE OR CONTRIBUTE TO INJURY DUE TO THE GARBAGE TRUCK ACCIDENT AND SUBSEQUENT DEATH, ACCORDING TO THE TREATING PHYSICIAN. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE INCIDENT OCCURRED IN KORTRIJK, BELGIUM, INCORRECTLY REPORTED AS GRONINGEN, BELGIUM IN THE INITAL MDR.

    Description of Event or Problem · 0

    ON THE 18TH OF OCTOBER, IN A HOSPITAL IN (B)(6), A PATIENT SAMPLE COULD NOT BE ANALYZED WITH ROTEM SIGMA SYSTEM DUE TO AN ERROR WHICH WAS DISPLAYED IN THE SYSTEM. THE PATIENT WAS IN A CRITICAL CONDITION AFTER BEING STUCK UNDER A GARBAGE TRUCK. PATIENT ARRIVED AT THE HOSPITAL AT ABOUT 8:35AM AND A MASSIVE TRANSFUSION PROTOCOL WAS INITIATED. THE SAMPLE FOR THE ROTEM SIGMA INSTRUMENT ARRIVED AT ABOUT 10:40AM. THERE WERE NO VISUAL PROBLEMS WITH THE SAMPLE IN THE TUBE, THE QUANTITY WAS SUFFICIENT. DURING THE TRANSFER OF THE SAMPLE FROM THE TUBE INTO THE CARTRIDGE, THE INSTRUMENT WAS NOT ABLE TO DETECT THE SAMPLE AND ABORTED THE MEASUREMENT (DRAW_BLOOD_2 ERROR MESSAGE SHOWN ON SCREEN). THE PHYSICIAN DECIDED TO GIVE FIBRINOGEN (WITHOUT RESULTS FROM ROTEM SIGMA) ON TOP OF THE TRANSFUSION PROTOCOL. A NEW SAMPLE WAS REQUESTED, HOWEVER FOR THE SECOND SAMPLE THE INSTRUMENT ABORTED THE MEASUREMENT AGAIN WITH THE SAME ERROR MESSAGE (11:12AM). CUSTOMER CONTACTED WERFEN WHICH RECOMMENDED TO PERFORM QUALITY CONTROL (QC) WHICH PASSED AT 13:02. THE HOSPITAL STAFF ALSO PERFORMED A TEST WITH A SAMPLE OF ANOTHER NORMAL PATIENT WITHOUT AN ERROR OF THE ROTEM SIGMA (NO TIME GIVEN). TOTAL AMOUNT OF BLOOD/ TRANSFUSION GIVEN: - 16 UNITS TRANSFUSION. - 10 UNITS PLASMA. - 1 UNIT PLATELETS. - + FIBRINOGEN. THE PATIENT DIED AT 13:55. DEATH IS NOT DIRECTLY LINKED BUT THE ROTEM SIGMA INSTRUMENT GAVE THE FOLLOWING ERROR TWO TIMES: DRAW_BLOOD_2. TRANSFUSION WAS DONE WITHOUT ROTEM SIGMA, HOWEVER THIS WAS NOT ACCORDING TO THE PROTOCOL OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668984 ROTEM SIGMA SYSTEM WHOLE BLOOD HAEMOSTASIS SYSTEM JPA TEM INNOVATIONS GMBH 04260160470372

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other