ROTEM DELTA SYSTEM
Received Mar 17, 2026 · Event occurred Feb 16, 2026
Report 3005792925-2026-00001 · MDR key 24621134
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Hypovolemic Shock
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.