BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTEM DELTA SYSTEM

    MDR report key: 24621134 · Received March 17, 2026

    Report

    Report Number
    3005792925-2026-00001
    Event Type
    Death
    Date Received
    March 17, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    TEM INNOVATIONS GMBH
    Product Code
    JPA
    PMA / PMN Number
    K101533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING RENAL SURGERY, HEMORRHAGE OCCURRED AND THE PATIENT EXPERIENCED HYPOVOLEMIC SHOCK RESULTING IN DEATH. MEDICAL REVIEW OF THE PROVIDED TOMOGRAMS AND CLINICAL SITUATION DID NOT FIND ANY EVIDENCE TO SUPPORT THAT THE RESULTS GIVEN BY ROTEM DELTA, SERIAL NUMBER (B)(6) WERE ERRONEOUS. EVALUATION OF THE COMPLETE PANEL OF ASSAYS DEMONSTRATED CONSISTENT FINDINGS ACROSS MULTIPLE INDEPENDENT CHANNELS, DEMONSTRATING PROLONGED CLOTTING TIMES (CTS) AND REDUCED CLOT AMPLITUDES. THIS CONCORDANT PATTERN IS STATISTICALLY UNLIKELY TO BE THE RESULT OF A LOCALIZED INSTRUMENT MALFUNCTION AND IS CLINICALLY CONSISTENT WITH SEVERE COAGULOPATHY. BASED ON THE PATIENT'S DOCUMENTED HYPOVOLEMIC SHOCK AND MANAGEMENT UNDER A MASSIVE HEMORRHAGE PROTOCOL, WERFEN'S MEDICAL TEAM DETERMINED THAT THE PROLONGED CTS AND REDUCED AMPLITUDES WERE MOST LIKELY ATTRIBUTABLE TO DILUTIONAL COAGULOPATHY ASSOCIATED WITH AGGRESSIVE FLUID RESUSCITATION. MANUFACTURING RECORDS CONFIRM THAT ROTEM DELTA, SERIAL NUMBER (B)(6), PASSED ALL MANUFACTURING AND QA SPECIFICATIONS PRIOR TO RELEASE. REVIEW OF THE COMPLAINT DATABASE IDENTIFIED NO TREND OR RECURRING FAILURE MODE RELEVANT TO THIS EVENT. AN ON-SITE SERVICE EVALUATION WAS CONDUCTED ON (B)(6) 2026. THE FIELD SERVICE ENGINEER VERIFIED PROPER SYSTEM FUNCTION, AND ALL SERVICE CHECKS AND LIQUID QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATION. THE ROOT CAUSE OF THE ELEVATED CT VALUES COULD NOT BE CONCLUSIVELY ESTABLISHED; HOWEVER, THE MOST PROBABLE CAUSE WAS THE PATIENT'S CLINICAL CONDITION AND TREATMENT. THERE IS NO EVIDENCE OF A PRODUCT QUALITY ISSUE RELATED TO THE MANUFACTURE, DESIGN, OR LABELING. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A CUSTOMER REPORTED AN EVENT INVOLVING THE ROTEM DELTA SYSTEM DURING A SURGICAL PROCEDURE. THE ROTEM DELTA DISPLAYED TRACINGS WITH MARKEDLY PROLONGED CLOTTING TIME (CT) IN THE FIBTEM, EXTEM, AND HEPTEM ASSAYS, WHICH WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION. THE PATIENT SUBSEQUENTLY EXPIRED; HOWEVER, PER THE INFORMATION PROVIDED, THE DEATH WAS ATTRIBUTED TO SURGICAL COMPLICATIONS UNRELATED TO THE DEVICE OR ITS ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682087 ROTEM DELTA SYSTEM WHOLE BLOOD HAEMOSTASIS SYSTEM JPA TEM INNOVATIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death