Fresenius HemaClip 04-9100-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10840861100825), received between Nov 20, 2017 and Apr 6, 2022 — classified as 6 deaths, 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathApr 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA USER FACILITY MEDWATCH (B)(4) THAT A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED A BLOOD LEAK (VENOUS LINE) DURING TREATMENT. SUBSEQUENTLY THE PATIENT WAS TRANSPORTED VIA EMERGENCY MEDICAL SERVICES (EMS) TO THE HOSPITAL, WHERE THEY LATER EXPIRED. A REVIEW OF THE PATIENT TREATMENT RECORD REVEALED THE PATIENT ARRIVED FOR HER REGULARLY SCHEDULED HD TREATMENT ON (B)(6) 2022. THE PATIENT¿S PRETREATMENT VITALS WERE: BLOOD PRESSURE (B/P) = 143/91, PULSE = 93 BPM, RESPIRATIONS = 17, TEMPERATURE = 97.5, WEIGHT = (B)(6) KGS. ADDITIONALLY, THE PRETREATMENT MACHINE CHECKS WERE ALL COMPLETED WITHOUT ISSUE. AT 1118 AM THE PATIENT¿S HD TREATMENT WAS INITIATED VIA A CENTRAL VENOUS CATHETER (CVC), AT A BLOOD FLOW RATE OF 400 ML/MIN. A PATIENT CONNECTOR CLIP (NO VISUAL DEFECTS) WAS APPLIED TO SECURE BOTH THE ARTERIAL AND VENOUS LUMENS OF THE HD CATHETER (NOT A FRESENIUS PRODUCT) TO THE COMBI-SET BLOOD LINES. AT 1132 AM, A PATIENT CARE TECHNICIAN RESPONDED TO A MACHINE ALARM AT THE PATIENT¿S STATION. BLOOD WAS NOTED ON THE UNDER-PAD AS WELL AS THE PATIENT'S CHEST AND ABDOMINAL AREA. THE BLOOD PUMP WAS IMMEDIATELY

  Patient problems: Loss of consciousness; Low Blood Pressure/ Hypotension

  MAUDE report 14018602 ↗
• DeathMar 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT ARRIVED FOR A REGULARLY SCHEDULED HD TREATMENT ON (B)(6) 2022. THE PATIENT¿S PRE-TREATMENT VITAL SIGNS WERE BLOOD PRESSURE (BP) 151/73, PULSE 69, RESPIRATION 18, AND TEMPERATURE 96.6. THE PATIENT¿S TREATMENT WAS INITIATED UTILIZING A FRESENIUS 2008T MACHINE WITH COMBI SET BLOODLINES AND FRESENIUS HEMACLIP BLOOD LINE CONNECTOR CLIP. AT APPROXIMATELY 0818 HOURS TREATMENT WAS INITIATED UTILIZING THE HEMODIALYSIS CENTRAL VENOUS CATHETER (CVC) AT A PRESCRIBED BLOOD FLOW RATE OF 400. THE HEMACLIP WAS SECURING THE CONNECTION BETWEEN THE CVC AND THE VENOUS BLOODLINE. WITHIN THE FIRST SEVERAL MINUTES OF TREATMENT INITIATION, THE REGISTERED NURSE (RN) DISCOVERED A POOL OF BLOOD UNDER THE PATIENT¿S CHAIR. THERE WAS APPROXIMATELY 100-300ML OF BLOOD NOTED. THE BLOOD PUMP WAS STOPPED BY THE RN AND THE BLOOD WAS NOTED TO BE ORIGINATING FROM THE VENOUS BLOODLINE/VENOUS LUMEN CONNECTION SITE. A CAROTID PULSE WAS PALPABLE. THE HD TREATMENT WAS TERMINATED, AND BLOOD WAS RETURNED USING THE ARTERIAL LUMEN OF THE CVC. AT 0827 HOURS THE PATIENT BECAME UNRESPONSIVE, EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS IN

  Patient problems: Cardiac Arrest

  MAUDE report 13804014 ↗
• DeathDec 27, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) EXPIRED. THE PATIENT¿S VENOUS BLOODLINE AND PATIENT CONNECTOR CLIP SEPARATED FROM THE HD CATHETER¿S (NOT A FRESENIUS PRODUCT) ARTERIAL LUMEN, RESULTING IN BLOOD LOSS TO THE PATIENT. ON (B)(6) 2019, THE PATIENT ARRIVED AT THE OUTPATIENT DIALYSIS CLINIC FOR THEIR REGULARLY SCHEDULED HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S PRE-TREATMENT VITAL SIGNS WERE AS FOLLOWS; BLOOD PRESSURE (BP) ¿ 113/71, HEART RATE (HR) ¿ 71 BEATS PER MIN (BPM), TEMPERATURE (TEMP) ¿ 95.0, RESPIRATIONS (RR) ¿ 18 AND WEIGHT ¿ 75.0 KG (4.0 KG ABOVE ESTIMATED DRY WEIGHT). THE PATIENT WAS ALERT AND ORIENTED AND DENIED ANY PAIN, SHORTNESS OF BREATH (DYSPNEA), NAUSEA, VOMITING OR DIARRHEA. THERE WAS NO REPORT OF VISIBLE DAMAGE TO THE PRODUCTS, AND ALL PRE-TREATMENT MACHINE CHECKS WERE PERFORMED WITHOUT ISSUE. THE HD TREATMENT WAS INITIATED AT 13:34 VIA A RIGHT CENTRAL VENOUS CATHETER (CVC). THE PATIENT¿S BP WAS 117/73 WITH A HR OF 70 BPM, AND THEY RECEIVED 2.0 LITERS OF OXYGEN VIA NASAL CANNULA AS ORDERED. AT 14:06, THE PATIENT¿S BLOOD FLOW RATE (BFR) WAS 350 ML/MIN, WITH A BP OF 96/65 AND A HR OF 67 BPM. AT 14:24 THE BLOOD LINE

  Patient problems: Congestive Heart Failure; Death; Loss Of Pulse; Loss of consciousness

  MAUDE report 9526527 ↗
• InjuryMay 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  REVIEW OF THE PATIENT¿S TREATMENT RECORD SHOWS THE HD REGISTERED NURSE WAS ALERTED THE PATIENT HAD BECOME UNRESPONSIVE (SYNCOPE);. IT WAS OBSERVED THAT THE VENOUS LUMEN OF THE DIALYSIS CATHETER AND THE VENOUS BLOODLINE HAD BECOME DISCONNECTED WITH THE HEMO-CLIP HOLDING BOTH ENDS TOGETHER IN PLACE WHICH RESULTED IN AN APPROXIMATE BLOOD LOSS OF 300 ML. THE PATIENT WAS TREATED BY CLAMPING THE SOURCE OF BLOOD LOSS, THE CONNECTION WAS SECURED, AND A BOLUS OF 1000 ML¿S OF 0.9% SODIUM CHLORIDE WAS GIVEN. FOLLOWING VOLUME REPLACEMENT, THE PATIENT BECAME RESPONSIVE AND BP WAS RECORDED AS 139/81 AND HR 100. ADDITIONALLY, THERE WERE REPORTS THE PATIENT INDICATED FEELING DIZZY, LIGHTHEADED AND NAUSEOUS; HOWEVER, PER NURSING DOCUMENTATION THIS HAD RESOLVED. TREATMENT RESUMED AS ORDERED REPORTEDLY WITH THE SAME MACHINE AND NEW SUPPLIES. SUBSEQUENTLY, PATIENT¿S BLOOD PRESSURE WAS RECORDED AS 83/49 AND AN ADDITIONAL 300 ML¿S OF 0.9% SODIUM CHLORIDE WAS GIVEN. SUBSEQUENTLY, THE PATIENT¿S BLOOD PRESSURE WAS 95/54, HR 104, AND THE PATIENT REPORTED EXPERIENCING CHEST AND JAW PAIN. PER DOCUMENTATION, THE PATIENT THEN RECEIVED AN ADDITIONAL 500 ML¿S OF FLUID REPLACEMENT AND THE TREATMENT WAS COMPLETED W

  Patient problems: Blood Loss; Chest Pain; Low Blood Pressure/ Hypotension; Syncope

  MAUDE report 8590813 ↗
• MalfunctionDec 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED A FRESENIUS PATIENT CONNECTOR CLIP THAT LEAKED APPROXIMATELY HALF WAY THROUGH A PATIENT¿S HEMODIALYSIS TREATMENT. THE TREATMENT WAS PAUSED, AND A NEW PATIENT CONNECTOR CLIP WAS USED TO COMPLETE THE TREATMENT. THE ESTIMATED BLOOD LOSS TO THE PATIENT WAS 125ML, AND THE PATIENT COMPLETED TREATMENT ON THE SAME MACHINE WITH NO INJURY, ADVERSE EVENT, OR MEDICAL INTERVENTION. THE DEVICE WAS REPORTEDLY DISCARDED, AND IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8170383 ↗
• DeathNov 26, 2018Disconnection; Fluid/Blood Leak; No Fail-Safe Mechanism; Disconnection; Fluid/Blood Leak; No Fail-Safe Mechanism

  A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A PATIENT EXPIRED FOLLOWING HEMODIALYSIS (HD) TREATMENT. SEVENTEEN MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT, IT WAS DISCOVERED THAT THE PRESCRIBED BLOOD FLOW RATE (BFR) COULD NOT BE ACHIEVED. STAFF REVERSED THE PATIENT¿S BLOODLINES IN AN EFFORT TO IMPROVE THE PATIENT¿S BFR, AND A HEMACLIP WAS APPLIED TO THE ARTERIAL LUMEN AND VENOUS BLOODLINE OF THE PATIENT¿S HD CATHETER; THE TREATMENT WAS RESTARTED. AT APPROXIMATELY 15:30, THE PATIENT WAS OBSERVED HAVING DIFFICULTY BREATHING AND WAS VISIBLY PALE, AND BLOOD WAS NOTED ON THE RIGHT FINGER. THE PATIENT¿S CATHETER PORTS WERE CLAMPED AND A SALINE BOLUS WAS ADMINISTERED. PABLO CONFIRMED THAT EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED AND CARDIOPULMONARY RESUSCITATIVE (CPR) WAS INITIATED. THE PATIENT EXPIRED IN THE EMERGENCY ROOM AT APPROXIMATELY 16:16. ADDITIONAL INFORMATION REGARDING THE PATIENT AND THE EVENT WAS REQUESTED, HOWEVER, NOT PROVIDED BY THE FACILITY. THE PATIENT CONNECTOR CLIP AND BLOODLINES WERE REPORTED TO HAVE BEEN DISCARDED AND ARE NOT AVAILABLE FOR MANUFACTURER EVALUATION.

  Patient problems: Blood Loss; Cardiopulmonary Arrest; Confusion/ Disorientation; Death; Dyspnea; Exsanguination

  MAUDE report 8103432 ↗
• InjuryOct 18, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018 A HEMODIALYSIS (HD) CLINIC REPORTED THAT A PATIENT WITH END STAGE RENAL DISEASE (ESRD) COMPLAINED OF SHORTNESS OF BREATH AND NAUSEA DURING TREATMENT. THE BLOODLINES HAD BEEN REVERSED EARLIER IN THE TREATMENT AND STAFF NOTED THE VENOUS BLOODLINE WAS LOOSE FROM THE CENTRAL VENOUS CATHETER (CVC) (NOT A FRESENIUS PRODUCT) ARTERIAL LIMB WITH HEMOCLIP INTACT. THE ESTIMATED BLOOD LOSS OF THE PATIENT WAS 400-500ML. THE PATIENT WAS ADMINISTERED OXYGEN AND EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND TRANSFERRED THE PATIENT TO THE HOSPITAL WHERE THEY WERE ADMITTED. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE CLINIC MANAGER ON (B)(6) 2018. THIS FEMALE PATIENT ON THRICE WEEKLY HD THERAPY INITIATED HER DIALYSIS TREATMENT ON (B)(6) 2018 UTILIZING THE OPTIFLUX 160NRE DIALYZER ON THE FRESENIUS 2008T MACHINE. THE TREATMENT WAS SCHEDULED FOR FOUR HOURS. WITH APPROXIMATELY 10 MINUTES REMAINING IN TREATMENT A BLOOD LEAK WAS OBSERVED AT THE CONNECTION BETWEEN THE VENOUS BLOODLINE AND THE CVC ARTERIAL LIMB CONNECTION. THE PATIENT THEN COMPLAINED OF NAUSEA AND DYSPNEA. PER THE CLINIC MANAGER, IT WAS NOT NOTED IF THERE WERE ANY LOOSE CONNECTIONS, HOWEVER, THERE WAS NO

  Patient problems: Dyspnea; Nausea

  MAUDE report 7980122 ↗
• InjuryMar 14, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A BLOOD LEAK OCCURRED DURING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED DUE TO A SEPARATION BETWEEN THE PATIENT¿S VENOUS LINE ON THE COMBISET AND THE ARTERIAL CATHETER PORT ON THE PATIENT¿S CENTRAL VENOUS CATHETER (CVC). PER THE NURSING NOTES, A HEMOSAFE WAS IN PLACE, HOWEVER, THE CLINICAL MANAGER REPORTED THAT THE HEMOSAFE WAS NOT FOUND AND WAS UNSURE IF IT WAS USED. TREATMENT WAS STOPPED AND THE PATIENT'S LINES WERE CLAMPED. THE PATIENT WAS REPORTED TO BE HYPOTENSIVE WITH A BLOOD PRESSURE OF 88/69. THE PATIENT BECAME CLAMMY AND BEGAN TO STARE OFF. NORMAL SALINE WAS ADMINISTERED (350 ML) AND THE PATIENT WAS NOTED TO BE ALERT AND RESPONSIVE. PER THE MEDICAL RECORDS, THE PATIENT WAS SET UP WITH NEW SUPPLIES AND TREATMENT WAS RESUMED. THE CLINICAL MANAGER REPORTED THAT THE PATIENT RECOVERED FROM THE EVENT AND WAS SENT HOME. THE CLINICAL MANAGER STATED THAT AN ADDITIONAL TREATMENT WAS RECOMMENDED, HOWEVER, THE PATIENT DECLINED. PER THE MEDICAL RECORDS, THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS REPORTED TO BE 200 ML. THE CENTRAL VENOUS CATHETER USED BY THE PATIENT IS A NON-FRESENIUS DEVICE. THE CLINICAL MANAGER R

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7340239 ↗
• MalfunctionFeb 27, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A HEMODIALYSIS (HD) NURSE REPORTED THAT A BLOOD LEAK OCCURRED BETWEEN A FRESENIUS BLOODLINE (COMBI SET) AND A CENTRAL VENOUS CATHETER (MANUFACTURER UNKNOWN) SECURED WITH A HEMOSAFE CLIP (BLOODLINE CONNECTOR). REPORTEDLY ALTHOUGH THE HEMOSAFE CLIP WAS IN PLACE THE BLOODLINE WAS NOT SECURE WITH THE VENOUS END OF THE CENTRAL VENOUS CATHETER. DURING A FOLLOW UP CALL TO THE HD NURSE ON 8/FEB/2018 IT WAS LEARNED THAT AN UNIDENTIFIED PATIENT EXPERIENCED A 400-600 ML BLOOD LOSS DURING A HD TREATMENT (DETAILS SURROUNDING TREATMENT ARE UNKNOWN) AS A RESULT OF A LEAK AT THE BLOOD LINE AND CENTRAL VENOUS LINE CONNECTION. IT WAS REPORTED THAT THE LEAK MAY HAVE OCCURRED AS THE RESULT OF THE LINES BEING MIS-TREADED. THE HD TREATMENT WAS STOPPED, AND ALL LINES WERE DISCARDED. THE PATIENT WAS ADMINISTERED SALINE AND OXYGEN (AMOUNTS AND DETAILS UNKNOWN) AND SENT TO THE EMERGENCY ROOM (MODE OF TRANSPORTATION UNKNOWN). REPORTEDLY, THE PATIENT HAD A 2 POINT DROP IN HEMOGLOBIN BUT, DID NOT RECEIVE A BLOOD TRANSFUSION. THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM WITHIN A COUPLE OF HOURS. THE HOSPITAL COURSE IS UNKNOWN. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL HD TREATMENTS AND HD TREATMENT HAS RES

  Patient problems: Blood Loss

  MAUDE report 7299065 ↗
• InjuryFeb 13, 2018Migration or Expulsion of Device; Device Slipped; Migration or Expulsion of Device; Device Slipped

  A CLINIC MANAGER REPORTED APPROXIMATELY TWO HOURS INTO SCHEDULED FOUR HOUR HEMODIALYSIS TREATMENT, PATIENT BEGAN COUGHING. PATIENT BECAME UNRESPONSIVE AND A MODERATE AMOUNT OF BLOOD WAS NOTED ON THE CHAIR, THE VENOUS BLOODLINE WAS NOTED TO BE LOOSE FROM THE CENTRAL VENOUS CATHETER (CVC) VENOUS LIMB, AND THE HEMOSAFE CLIP WAS NOTED TO BE DISLODGED FROM THE VENOUS BLOODLINE/CVC LIMB. THE BLOOD PUMP WAS TURNED OFF AND THE VENOUS BLOODLINE WAS RESECURED TO THE VENUS LIMB OF THE CVC. 500 ML NORMAL SALINE BOLUS WAS ADMINISTERED, OXYGEN APPLIED. BLOOD PRESSURE (BP) WAS 170/91, PULSE 109. STAFF WERE UNABLE TO AROUSE PATIENT, WHO HAD A WEAK PULSE. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND 911 WAS CALLED. PATIENT BECAME RESPONSIVE AFTER A FEW COMPRESSIONS WERE ADMINISTERED. AN ADDITIONAL 500 ML NORMAL SALINE WAS GIVEN. EMS ARRIVED. BP WAS 164/85, PULSE 89. THE CVC WAS FLUSHED AND CAPPED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND WAS AWAKE, ALERT AND RESPONSIVE WITH BP 116/70 UPON DISCHARGE FROM FACILITY. PATIENT WAS ADMITTED TO THE HOSPITAL AND RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS. HE WAS DISCHARGED ON (B)(6) 2018. ADDITIONAL FOLLOW-UP MADE WITH THE CLINIC MANAGER REV

  Patient problems: Anemia; Blood Loss; Hypovolemia; Loss of consciousness; Low Blood Pressure/ Hypotension

  MAUDE report 7267697 ↗
• DeathJan 12, 2018Failure To Adhere Or Bond; Connection Problem; Failure To Adhere Or Bond; Connection Problem

  INFORMATION IN THE COMPLAINT FILE WAS REVIEWED BY A POTS MARKET SURVEILLANCE CLINICIAN. ON (B)(6) 2017, A COPY OF A VOLUNTARY MEDWATCH WAS RECEIVED FROM A HEMODIALYSIS (HD) CLINIC THAT WAS PREVIOUSLY SUBMITTED TO THE FDA FOR THIS (B)(6) FEMALE END STAGE RENAL DISEASE (ESRD) PATIENT ON IN-CENTER HD FOR RENAL REPLACEMENT THERAPY (RRT) TO MAKE NOTIFICATION THAT THE PATIENT EXPIRED DURING HD TREATMENT. ON (B)(6) 2017, APPROXIMATELY 2 ¼ HOURS INTO A SCHEDULED 3 HOUR HD TREATMENT, THE PATIENT WAS FOUND UNRESPONSIVE. THE VENOUS BLOODLINE WAS NOTED TO BE DISCONNECTED FROM THE TUNNELED JUGULAR CENTRAL VENOUS CATHETER (NOT A FRESENIUS PRODUCT) WITH THE HEMACLIP STILL IN PLACE. THE PATIENT WAS LAST CHECKED 10 MINUTES PRIOR TO THE PATIENT BEING FOUND UNRESPONSIVE WITH A BLOOD PRESSURE 141/54 AND PULSE 98. THE VENOUS BLOODLINE AND CENTRAL VENOUS CATHETER LINE WERE THEN CLAMPED AND THE BLOOD PUMP STOPPED. THE PATIENT WAS PLACED ON HER LEFT SIDE, OXYGEN WAS APPLIED AND 911 WAS CALLED. THE AUTOMATED EXTERNAL DEFIBRILLATOR (AED) WAS APPLIED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. A TOTAL OF 400ML NORMAL SALINE WAS INFUSED (UNKNOWN INTRAVENOUS (IV) SITE) AND TWO SHOCKS WERE ADMINISTER

  Patient problems: Blood Loss; Cardiopulmonary Arrest; Death; Hypovolemia

  MAUDE report 7188246 ↗
• MalfunctionDec 27, 2017Disconnection; Leak/Splash; Disconnection; Leak/Splash

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  Patient problems: Anemia; Blood Loss; Hypothermia; Low Blood Pressure/ Hypotension

  MAUDE report 7147953 ↗
• DeathNov 20, 2017Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  ON (B)(6) 2017, APPROXIMATELY ONE AND A HALF HOURS INTO A SCHEDULED FOUR HOUR HEMODIALYSIS (HD) TREATMENT, BLOOD WAS NOTED ON THE FLOOR TO THE RIGHT OF THE PATIENT¿S CHAIR. THIS WAS OBSERVED DURING A RANDOM CHECK BY A STAFF MEMBER AS THE PREVIOUS PATIENT CHECK AT AN UNKNOWN TIME WAS UNEVENTFUL WITH NO PATIENT COMPLAINTS OR SYMPTOMS. THE VENOUS BLOODLINE WAS DETACHED FROM THE VENOUS LUMEN OF THE CENTRAL VENOUS CATHETER. THE MACHINE DID NOT ALARM. THE BLOOD PUMP WAS STOPPED AND THE LUMEN WAS CLAMPED. THE PATIENT WAS UNRESPONSIVE. THE ESTIMATED BLOOD LOSS (EBL) WAS REPORTED TO BE BETWEEN 100-300ML AND THE NURSE STATED THAT THE PATIENT BECAME UNRESPONSIVE DUE TO THE BLOOD LOSS. THE STAFF ADMINISTERED OXYGEN, THE AUTOMATED EXTERNAL DEFIBRILLATOR (AED) WAS APPLIED, CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND 911 WAS CALLED. NORMAL SALINE WAS INFUSED VIA THE PATIENT¿S ARTERIAL LINE. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMERGENCY MEDICAL SERVICES (EMS) AND LATER EXPIRED. THE HEMACLIPS WERE APPLIED TO BOTH ARTERIAL AND VENOUS LINES AT THE INITIATION OF THE PATIENT¿S TREATMENT. THE CAUSE OF DEATH IS STATED AS CARDIOPULMONARY DEATH AND HYPOVOLEMIA. IT IS UNKNOWN HOW THE

  Patient problems: Blood Loss; Death; Hypovolemia; Loss of consciousness

  MAUDE report 7046768 ↗