OrganOx metra D0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 05060462240005), received between May 10, 2024 and Nov 26, 2024 — classified as 1 death, 34 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 reports).

1 other recall cover devices cleared under the same FDA submission (P200035); they may or may not involve this specific model.

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 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Decreased Pump Speed; Decreased Pump Speed

  THE DEVICE USER (DU) REPORTED THAT THE RECIRCULATION PUMP SEEMED TO BE PUMPING AT A LOWER RATE THAN PREVIOUS PUMPS. IT WAS NOTED THAT THE LIVER WAS TRANSPLANTED WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782238 ↗
• MalfunctionNov 26, 2024Decreased Pump Speed; Decreased Pump Speed

  THE DEVICE USER (DU) REPORTED THAT THE RECIRCULATION PUMP SEEMED TO BE PUMPING AT A LOWER RATE THAN PREVIOUS PUMPS. IT WAS NOTED THAT THE LIVER WAS TRANSPLANTED WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780367 ↗
• MalfunctionNov 26, 2024Decreased Pump Speed; Decreased Pump Speed

  THE DEVICE USER (DU) REPORTED THAT THE RECIRCULATION PUMP SEEMED TO BE PUMPING AT A LOWER RATE THAN PREVIOUS PUMPS. IT WAS NOTED THAT THE LIVER WAS TRANSPLANTED WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777969 ↗
• InjuryNov 14, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT A LIVER WAS PLACED ON THE DEVICE AT 2 AM UTC FOR LOGISTICS. IT WAS NOTED THAT ARTERIAL FLOW HAD STEADILY DROPPED SINCE THE START OF THE CASE, PEAKING AT 0.3 L/MIN. THE DEVICE USER (DU) TEAM HAD ADJUSTED THE CANNULA POSITION WITH SOME IMPROVEMENT (0 TO 0.1 L/MIN), BUT SUBSEQUENTLY THE FLOW HAD FALLEN AGAIN. THE DU HAD ENSURED THE SYRINGE DRIVER WAS FUNCTIONING AND IT WAS CONFIRMED THAT APPROXIMATELY 5 ML OF INFUSIONS WERE DELIVERED IN CORRELATION TO THE 5 HOURS OF PERFUSION AT THE TIME. VOLUME WAS SAFELY REMOVED FROM THE RESERVOIR TO CONFIRM THAT THE RESERVOIR WAS NOT TOO FULL. FLOWS IMPROVED BRIEFLY AFTERWARDS, BUT RETURNED BACK TO 0 L/MIN. THEN, THE DU RETURNED TO THE LIVER BOWL TO CHECK THE ARTERY AND WHILE LOOKING AT ARTERIAL PRESSURE COULD NOT SEE ANY IMPROVEMENT. THEY ALSO CONFIRMED THAT THE AIRKNOT WAS NOT PLACED TOO TIGHTLY OR HIGHLY ON THE ARTERIAL CANNULA. SUBSEQUENTLY, IT WAS DECIDED THE LIVER WOULD BE DISCARDED.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20684512 ↗
• MalfunctionNov 13, 2024Failure to Charge; Failure to Charge

  THE DEVICE USER (DU) REPORTED MESSAGE CODE 80 (LOW BATTERY) ON THE METRA. THEY HAD ALREADY CHANGED OUT THE POWER CORD AND OUTLETS, BUT THE BATTERY WAS STILL NOT CHARGING. THE CLINICAL SPECIALIST (CS) ASSISTED THE DEVICE USER WITH TROUBLESHOOTING AND AT THE TIME, THE BATTERY WAS AT 44 PERCENT. IT WAS NOTED THAT THE LIVER WAS NOT ON BOARD AT THE TIME. THE DU WAS GUIDED THROUGH A HARD RESET OF THE DEVICE. THIS RESOLVED THE ISSUE AND THE BATTERY CHARGE INCREASED TO 47 PERCENT IN LESS THAN 30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677272 ↗
• MalfunctionNov 12, 2024Restricted Flow rate; Restricted Flow rate

  THE DEVICE USER (DU) REPORTED THAT THEY EXPERIENCED LOW INFERIOR VENA CAVA (IVC) OUTFLOW (< 1.5 L/MIN) AND LOW ARTERIAL FLOW (0.0 TO 0.1 L/MIN) AS WELL AS SUCTION EVENTS FURTHER INTO THE PERFUSION RUN. THE DU WAS CONCERNED THAT THERE MAY BE A DEVICE PROBLEM AND REQUESTED DIAGNOSTIC TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20670756 ↗
• MalfunctionNov 12, 2024Restricted Flow rate; Restricted Flow rate

  THE DEVICE USER (DU) REPORTED THAT THEY EXPERIENCED LOW INFERIOR VENA CAVA (IVC) OUTFLOW (< 1.5 L/MIN) AND LOW ARTERIAL FLOW (0.0 TO 0.1 L/MIN) AS WELL AS SUCTION EVENTS FURTHER INTO THE PERFUSION RUN. THE DU WAS CONCERNED THAT THERE MAY BE A DEVICE PROBLEM AND REQUESTED DIAGNOSTIC TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668001 ↗
• MalfunctionNov 8, 2024Premature Discharge of Battery; Premature Discharge of Battery

  THE DEVICE USER (DU) REPORTED MESSAGE CODE 80 (LOW BATTERY) AND A DECREASING BATTERY. THE DU STATED THAT WHEN INITIALLY PLUGGING IN THE METRA INTO THE VEHICLE INVERTER, THEY WERE ABLE TO VISUALIZE THE PLUG ICON ON THE GRAPHICAL USER INTERFACE (GUI) SCREEN AND THE GREEN LIGHT ILLUMINATED ON THE MAINS POWER SWITCH. AFTER ABOUT TWO HOURS, THEY HEARD THE ALARM AND SAW MESSAGE CODE 80. THE DU COMPLETED TROUBLESHOOTING BY PERFORMING A POWER CYCLE ON THE INVERTER AND SWAPPING THE DEVICE PLUG TO A NEW OUTLET. AFTERWARDS, THE BATTERY WAS VERIFIED TO BE INCREASING. THE DU WAS ASKED TO CONTINUE TO WATCH AND REPORT THAT THE BATTERY WAS INCREASING. THEY SENT A FEW IMAGES OVER TIME INDICATING THAT THE BATTERY WAS SLOWLY INCREASING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641995 ↗
• InjuryNov 6, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE DEVICE BEGAN TO CONTINUALLY ENTER AND CYCLE THROUGH LOW RESERVOIR MODE. IT WAS DETERMINED THAT THE DEVICE USER (DU) HAD USED COPIOUS AMOUNT OF SURGICEL RESULTING IN SEPARATION OF PERFUSATE IN THE RESERVOIR BAG. DURING TROUBLESHOOTING, A CLINICAL SPECIALIST (CS) CONFIRMED THAT ASCITES PUMP WAS NOT WORKING AND THE GRAPHICAL USER INTERFACE SCREEN WAS READING "1" ON THE ASCITES FIELD. THE ASCITES PUMP BEGAN WORKING AGAIN FOLLOWING TROUBLESHOOTING, BUT THE DEVICE CONTINUED TO CYCLE LOW RESERVOIR MODE DUE TO BLEEDING AND FLUID SEPARATION IN THE RESERVOIR BAG. GUIDANCE FOR RESOLVING HEMOSTASIS WAS PROVIDED TO THE DU AND IT WAS RECOMMENDED THAT THE DONOR LIVER BE COLD FLUSHED IF THEY WERE UNABLE TO ACHIEVE STABLE PERFUSION. SUBSEQUENTLY, THE DU DECIDED TO DISCARD THE DONER LIVER DUE TO UNSTABLE PERFUSION CAUSED BY EXCESSIVE BLEEDING AND INABILITY TO CONTROL HEMOSTASIS. WHILE THE ASCITES PUMP FAILURE WAS SAID TO HAVE CONTRIBUTED TO EARLY INSTABILITY TO THE PERFUSION, THE INABILITY TO CONTROL HEMOSTASIS AND USE OF A SEALANT CONTRIBUTED TO REPEATED LOW RESERVOIR MODE AND AN OVERALL UNSTABLE PERFUSION FOLLOWING THE COMPLETION OF TROUBLESHOOTING.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20617323 ↗
• InjuryNov 6, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE DEVICE BEGAN TO CONTINUALLY ENTER AND CYCLE THROUGH LOW RESERVOIR MODE. IT WAS DETERMINED THAT THE DEVICE USER (DU) HAD USED COPIOUS AMOUNT OF SURGICEL RESULTING IN SEPARATION OF PERFUSATE IN THE RESERVOIR BAG. DURING TROUBLESHOOTING, A CLINICAL SPECIALIST (CS) CONFIRMED THAT ASCITES PUMP WAS NOT WORKING AND THE GRAPHICAL USER INTERFACE SCREEN WAS READING "1" ON THE ASCITES FIELD. THE ASCITES PUMP BEGAN WORKING AGAIN FOLLOWING TROUBLESHOOTING, BUT THE DEVICE CONTINUED TO CYCLE LOW RESERVOIR MODE DUE TO BLEEDING AND FLUID SEPARATION IN THE RESERVOIR BAG. GUIDANCE FOR RESOLVING HEMOSTASIS WAS PROVIDED TO THE DU AND IT WAS RECOMMENDED THAT THE DONOR LIVER BE COLD FLUSHED IF THEY WERE UNABLE TO ACHIEVE STABLE PERFUSION. SUBSEQUENTLY, THE DU DECIDED TO DISCARD THE DONER LIVER DUE TO UNSTABLE PERFUSION CAUSED BY EXCESSIVE BLEEDING AND INABILITY TO CONTROL HEMOSTASIS. WHILE THE ASCITES PUMP FAILURE WAS SAID TO HAVE CONTRIBUTED TO EARLY INSTABILITY TO THE PERFUSION, THE INABILITY TO CONTROL HEMOSTASIS AND USE OF A SEALANT CONTRIBUTED TO REPEATED LOW RESERVOIR MODE AND AN OVERALL UNSTABLE PERFUSION FOLLOWING THE COMPLETION OF TROUBLESHOOTING.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20617267 ↗
• InjuryNov 6, 2024Incorrect Measurement; Incorrect Measurement

  THE DEVICE USER (DU) REPORTED THAT THE METRA WAS NOT TRANSITIONING FROM PREPARATION MODE TO LIVER ON BOARD MODE. TROUBLESHOOTING WAS ATTEMPTED AT FIRST WITH NO RESOLUTION. THE SURGEON WAS GUIDED THROUGH FURTHER TROUBLESHOOTING BY A CLINICAL RESEARCH ENGINEER (CRE) TO INCREASE ARTERIAL PRESSURE AND INDUCE LIVER ON BOARD MODE. IT WAS DETERMINED THAT THE INFERIOR VENA CAVA (IVC) PRESSURE SENSOR WAS NOT FUNCTIONING PROPERLY. THE IVC PRESSURED CONSISTENTLY MEASURED AS 19 MMHG THROUGHOUT THE PERFUSION. SUBSEQUENTLY, THE DU DECIDED TO DISCARD THE DONER LIVER DUE TO UNSTABLE PERFUSION CAUSED BY EXCESSIVE BLEEDING AND INABILITY TO CONTROL HEMOSTASIS. THE REPORTED PRESSURE FAILURE WAS SAID TO HAVE CONTRIBUTED TO EARLY PERFUSION INSTABILITY ALSO.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20616670 ↗
• InjuryNov 5, 2024Incorrect Measurement; Incorrect Measurement

  THE DEVICE USER (DU) REPORTED THAT THE METRA WAS NOT TRANSITIONING FROM PREPARATION MODE TO LIVER ON BOARD MODE. TROUBLESHOOTING WAS ATTEMPTED AT FIRST WITH NO RESOLUTION. THE SURGEON WAS GUIDED THROUGH FURTHER TROUBLESHOOTING BY A CLINICAL RESEARCH ENGINEER (CRE) TO INCREASE ARTERIAL PRESSURE AND INDUCE LIVER ON BOARD MODE. IT WAS DETERMINED THAT THE INFERIOR VENA CAVA (IVC) PRESSURE SENSOR WAS NOT FUNCTIONING PROPERLY. THE IVC PRESSURED CONSISTENTLY MEASURED AS 19 MMHG THROUGHOUT THE PERFUSION. SUBSEQUENTLY, THE DU DECIDED TO DISCARD THE DONER LIVER DUE TO UNSTABLE PERFUSION CAUSED BY EXCESSIVE BLEEDING AND INABILITY TO CONTROL HEMOSTASIS. THE REPORTED PRESSURE FAILURE WAS SAID TO HAVE CONTRIBUTED TO EARLY PERFUSION INSTABILITY ALSO.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20615395 ↗
• MalfunctionOct 23, 2024High Readings; High Readings

  IT WAS REPORTED THAT THE ARTERIAL FLOW WAS OVER READING BY APPROXIMATELY 190 ML PER MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516781 ↗
• MalfunctionOct 10, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING THE CASE THE DEVICE USER (DU) HAD TO RECALIBRATE THE METRA FOUR TIMES. IT WAS NOTED THAT THERE WERE SIGNIFICANT DISCREPANCIES IN PO2 LEVELS WHEN COMPARED TO THEIR LAB MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417020 ↗
• InjuryOct 1, 2024Failure to Deliver; Failure to Deliver

  AT 240 AM EST, THE DEVICE USER (DU) REPORTED LOW RESERVOIR MODE AND CYCLING RESERVOIR ISSUES THREE HOURS AND THIRTEEN MINUTES INTO PERFUSION. DURING TROUBLESHOOTING, IT WAS CONFIRMED THAT THERE WAS VOLUME COLLECTING AT THE BOTTOM OF THE LIVER BOWL, BUT THERE WERE NO KINKS IN THE TUBING. IT WAS RECOMMENDED THAT THE SURGEON INSPECT THE LIVER TO RESOLVE HEMOSTASIS. AT 333 AM EST THE DU REPORTED THERE WERE NO FLOWS ON THE MACHINE, THE RESERVOIR VOLUME WAS EMPTY AND VOLUME WAS COLLECTING AT THE BOTTOM OF THE LIVER BOWL. TROUBLESHOOTING WAS PERFORMED AND IT WAS CONFIRMED THAT THE CENTRIFUGAL PUMP WAS WORKING BUT THE ASCITES PUMP WAS NOT RUNNING DESPITE "1" BEING LISTED FOR ASCITES ON THE GRAPHICAL INTERFACE SCREEN. AFTER POWERING THE DEVICE OFF AND BACK ON, IT WAS CONFIRMED THAT THE ASCITES PUMP WAS FUNCTIONING AND VOLUME WAS RETURNING TO THE RESERVOIR. PRIOR TO THIS RESOLUTION, LACK OF FLOW LASTED ABOUT ONE HOUR. AS A RESULT, THE LIVER'S LACTATE INCREASED FROM 0.88 TO 8.44. THE DU DECLINED TO USE THE DONOR LIVER DUE TO THE INABILITY TO CLEAR LACTATE ADEQUATELY, BUT CONTINUED WITH THE PERFUSION IN CASE ANOTHER SITE WISHED TO TAKE THE DONOR LIVER. SUBSEQUENTLY, THE ASCITES PUMP STOPPED WO

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20344250 ↗
• InjuryOct 1, 2024Failure to Deliver; Failure to Deliver

  AT 240 AM EST, THE DEVICE USER (DU) REPORTED LOW RESERVOIR MODE AND CYCLING RESERVOIR ISSUES THREE HOURS AND THIRTEEN MINUTES INTO PERFUSION. DURING TROUBLESHOOTING, IT WAS CONFIRMED THAT THERE WAS VOLUME COLLECTING AT THE BOTTOM OF THE LIVER BOWL, BUT THERE WERE NO KINKS IN THE TUBING. IT WAS RECOMMENDED THAT THE SURGEON INSPECT THE LIVER TO RESOLVE HEMOSTASIS. AT 333 AM EST THE DU REPORTED THERE WERE NO FLOWS ON THE MACHINE, THE RESERVOIR VOLUME WAS EMPTY AND VOLUME WAS COLLECTING AT THE BOTTOM OF THE LIVER BOWL. TROUBLESHOOTING WAS PERFORMED AND IT WAS CONFIRMED THAT THE CENTRIFUGAL PUMP WAS WORKING BUT THE ASCITES PUMP WAS NOT RUNNING DESPITE "1" BEING LISTED FOR ASCITES ON THE GRAPHICAL INTERFACE SCREEN. AFTER POWERING THE DEVICE OFF AND BACK ON, IT WAS CONFIRMED THAT THE ASCITES PUMP WAS FUNCTIONING AND VOLUME WAS RETURNING TO THE RESERVOIR. PRIOR TO THIS RESOLUTION, LACK OF FLOW LASTED ABOUT ONE HOUR. AS A RESULT, THE LIVER'S LACTATE INCREASED FROM 0.88 TO 8.44. THE DU DECLINED TO USE THE DONOR LIVER DUE TO THE INABILITY TO CLEAR LACTATE ADEQUATELY BUT CONTINUED WITH THE PERFUSION IN CASE ANOTHER SITE WISHED TO TAKE THE DONOR LIVER. SUBSEQUENTLY, THE ASCITES PUMP STOPPED WOR

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20343995 ↗
• InjurySep 26, 2024High Readings; High Readings

  THE DEVICE USER (DU) REPORTED CONCERNS WITH PO2 DISCREPANCY BETWEEN THE METRA AND THEIR BLOOD GAS DEVICE ONE HOUR INTO THE PERFUSION. WHILE TROUBLESHOOTING WAS BEING COMPLETED, IT APPEARED THAT THE ISSUE MIGHT BE A FLUCTUATING PO2 WHICH GAVE THE APPEARANCE OF A DIFFERENCE. IT WAS CONFIRMED THE FLOWS WERE STABLE. THE DU PLOTTED THE PO2 ON THE GRAPHICAL USER INTERFACE (GUI) TO CONFIRM HISTORICAL PO2 LEVELS WHICH SHOWED LOTS OF VARIATION. AN IMAGE OF THE GUI SHOWED FOUR PERCENT O2 DELIVERY TO THE LIVER. A MANUAL CALIBRATION WAS COMPLETED WHICH SHOWED A SMALL OFFSET OF 12KPA TO 7KPA WHICH THE DU WAS PLEASED WITH. HOWEVER, SUBSEQUENTLY THE DU REACHED OUT AGAIN TO REPORT THAT THE INSTABILITY OF PO2 RETURNED. THE LIVER WAS DISCARDED BECAUSE VIABILITY CRITERIA WAS NOT MET. IN PARTICULAR, LACTATE INCREASED DRASTICALLY AFTER AN INITIAL DROP BEFORE THE OXYGENATION ISSUE. IN ADDITION, BILIARY PARAMETERS WORSENED TOWARDS THE END OF PERFUSION.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20311276 ↗
• InjurySep 26, 2024High Readings; High Readings

  THE DEVICE USER (DU) REPORTED CONCERNS WITH PO2 DISCREPANCY BETWEEN THE METRA AND THEIR BLOOD GAS DEVICE ONE HOUR INTO THE PERFUSION. WHILE TROUBLESHOOTING WAS BEING COMPLETED, IT APPEARED THAT THE ISSUE MIGHT BE A FLUCTUATING PO2 WHICH GAVE THE APPEARANCE OF A DIFFERENCE. IT WAS CONFIRMED THE FLOWS WERE STABLE. THE DU PLOTTED THE PO2 ON THE GRAPHICAL USER INTERFACE (GUI) TO CONFIRM HISTORICAL PO2 LEVELS WHICH SHOWED LOTS OF VARIATION. AN IMAGE OF THE GUI SHOWED FOUR PERCENT O2 DELIVERY TO THE LIVER. A MANUAL CALIBRATION WAS COMPLETED WHICH SHOWED A SMALL OFFSET OF 12KPA TO 7KPA WHICH THE DU WAS PLEASED WITH. HOWEVER, SUBSEQUENTLY THE DU REACHED OUT AGAIN TO REPORT THAT THE INSTABILITY OF PO2 RETURNED. THE LIVER WAS DISCARDED BECAUSE VIABILITY CRITERIA WAS NOT MET. IN PARTICULAR, LACTATE INCREASED DRASTICALLY AFTER AN INITIAL DROP BEFORE THE OXYGENATION ISSUE. IN ADDITION, BILIARY PARAMETERS WORSENED TOWARDS THE END OF PERFUSION.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20311017 ↗
• MalfunctionSep 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  THE DEVICE USER (DU) REPORTED THAT THE DEVICE BATTERY WAS AT 48 PERCENT AND MESSAGE 80 (LOW BATTERY) WAS PRESENT. THE DU SAID THAT THE DEVICE WAS ONLY UNPLUGGED FOR ROUGHLY 10 TO 15 MINUTES. THEY MENTIONED THAT THEY DID NOT NOTICE A SUDDEN DROP IN BATTERY PERCENTAGE AND DID NOT NOTICE THE LOW BATTERY UNTIL IT WAS ALARMING. THE CUSTOMER HAD MOVED THE DEVICE TO A SUB STERILE ROOM IN THE OPERATING ROOM (OR) FOR A WHILE, BUT THE DEVICE WAS PLUGGED IN AND THE GREEN MAINS POWER SWITCH WAS ON. ONCE THE DEVICE WAS IN THE RECIPIENT OR, THE DU NOTICED THE DEVICE WAS CHARGING WHEN USING THAT OUTLET. THE DU WAS INSTRUCTED TO TEST THE OUTLET IN THE SUB STERILE ROOM WITH OTHER EQUIPMENT AND IT WAS NOTED THAT THE OUTLET WORKED. THE DU WAS ALSO ASKED TO TEST THE OUTLET IN THE SUB STERILE ROOM WITH THE DEVICE AFTER THE LIVER WAS TAKEN OFF. THE DU CONFIRMED THAT THE DEVICE WAS PLUGGED IN AND CHARGING AT ITS STORAGE LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305742 ↗
• MalfunctionSep 23, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE DEVICE USER (DU) REPORTED THAT THERE WAS A LOOSE WATER CONNECTION ON THE DEVICE. THEY WERE ASKED TO ENSURE IT WAS PROPERLY HEATING PERFUSATE AND THEY CONFIRMED THAT IT WAS WORKING FINE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20284978 ↗
• InjurySep 13, 2024Restricted Flow rate; Restricted Flow rate

  THE DEVICE USER (DU) REPORTED ARTERIAL FLOW WAS LOW. INITIALLY ARTERIAL FLOW WAS GOOD (0.4L/MIN). BUT, IT TAPERED OFF AFTER A FEW MINUTES. AS A RESULT OF THE FLOW ISSUE, THE DU DECIDED TO DISCARD THE DONOR LIVER.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20212855 ↗
• InjurySep 13, 2024Restricted Flow rate; Restricted Flow rate

  THE DEVICE USER (DU) REPORTED ARTERIAL FLOW WAS LOW. INITIALLY ARTERIAL FLOW WAS GOOD (0.4L/MIN). BUT, IT TAPERED OFF AFTER A FEW MINUTES. AS A RESULT OF THE FLOW ISSUE, THE DU DECIDED TO DISCARD THE DONOR LIVER.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20212564 ↗
• InjurySep 12, 2024Restricted Flow rate; Restricted Flow rate

  THE DEVICE USER REPORTED ARTERIAL FLOW WAS LOW. INITIALLY THE DEVICE WAS PERFUSING AS THEY EXPECTED, BUT SEVERAL HOURS INTO THE PERFUSION THE ARTERIAL FLOW BEGAN TO TAPER OFF (FROM 0.4L/MIN TO 0.1 L/MIN). THEY DID VARIOUS TROUBLESHOOTING TECHNIQUES TO NO AVAIL. AS A RESULT, THE LIVER WAS DISCARDED.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20207843 ↗
• InjurySep 12, 2024Restricted Flow rate; Restricted Flow rate

  THE DEVICE USER REPORTED ARTERIAL FLOW WAS LOW. INITIALLY THE DEVICE WAS PERFUSING AS THEY EXPECTED, BUT SEVERAL HOURS INTO THE PERFUSION THE ARTERIAL FLOW BEGAN TO TAPER OFF (FROM 0.4L/MIN TO 0.1 L/MIN). THEY DID VARIOUS TROUBLESHOOTING TECHNIQUES TO NO AVAIL. AS A RESULT, THE LIVER WAS DISCARDED.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20205609 ↗
• MalfunctionSep 10, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE OXYGENATOR WAS DARK AND NOT GETTING OXYGEN DELIVERED. THE CUSTOMER WAS ASKED TO ENSURE THE CONCENTRATOR LINE WAS PLUGGED IN CORRECTLY. THEY WERE ABLE TO REMOVE AND RECONNECT THE LINE WITH NO CHANGE. MESSAGE CODES 410 (LOW BLOOD OXYGEN LEVELS) AND 2410 (CRITICAL FAULT REPORTED) WERE PRESENT ON THE SCREEN. THE CUSTOMER WAS THEN ASKED TO PERFORM A STOP START AND THE ISSUE WAS RESOLVED. THE CUSTOMER ENSURED THAT THE LEVELS OF PO2 WERE RISING AND STABILIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184762 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200035. One submission often covers many models, so check the product and lot details in each record.

• Z-0501-2025 · Oct 15, 2024 · Open, Classified
  OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to