OrganOx metra D0146Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05060462240029), received between Mar 1, 2024 and Nov 13, 2024 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 15, 2024Class IIOpen, Classified

   Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

   Z-0501-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2024Complete Blockage; Complete Blockage

  THE DEVICE USER REPORTED THAT THEY HAD A LIVER GOING ON PUMP OVERNIGHT. AT 327 AM EST THE DEVICE USER SENT A MESSAGE STATING "LIVER IS BEING DISCARDED. THERE WAS A DEFECT IN THE RECIRCULATING PUMP LINE THAT PREVENTED THE PUMP FROM REFILLING THE RESERVOIR BAG. THAT COMBINED WITH A HEAVY BLEEDER PREVENTED THE LIVER FROM GETTING PROPER PERFUSION." THE DEVICE USER FURTHER DESCRIBED THAT THE TUBING UNDER THE LIVER BOWL WAS SEALED SHUT AND SINCE IT WAS UNDER THE LIVER BOWL, THEY COULD NOT FIGURE OUT WHY THE RECIRCULATING PUMP WAS SLOW. BY THE TIME THE AREA WAS LOCATED, IT HAD BEEN A LONG TIME WITH AN EMPTY RESERVOIR. IT WAS NOTED THAT THE SEAL TOOK SEVERAL MINUTES TO BREAK AND THE TUBING WAS ALMOST COMPLETELY OCCLUDED AS WELL.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 20679745 ↗
• InjuryJul 18, 2024Restricted Flow rate; Restricted Flow rate

  THE DEVICE USER (DU) REPORTED THAT THERE WAS LITTLE TO NO FLOW NOTED AFTER THE LIVER WAS CONNECTED TO THE DEVICE. DURING TROUBLESHOOTING A DARKENED AREA AT THE TOP OF THE SOFT-SHELL RESERVOIR WAS NOTED AND AIR WAS OBSERVED IN THE TUBING. THE DECISION WAS MADE TO REMOVE THE LIVER AND COLD FLUSH TO AVOID WARM ISCHAEMIA TIME. FOLLOWING ADDITIONAL TROUBLESHOOTING, THE DU DISCOVERED A CLOT IN THE PORTAL CANNULA. THE DEVICE WAS CLEARED OF AIR AND PREPARATION MODE WAS ACHIEVED. IT WAS CONFIRMED THAT THE DU USED THE RECOMMENDED INFUSIONS, BOLUS DRUGS & PRIMING STEPS. ABOUT ONE HOUR LATER THE DU REPORTED THAT THE DEVICE ENTERED LOW RESERVOIR MODE. THIS WAS RESOLVED BY MANIPULATING THE RECIRCULATION PUMP SENSOR RESULTING IN THE VOLUME IN THE BOWL RECIRCULATING INTO THE RESERVOIR. ULTIMATELY, THE DU DECIDED TO DISCARD THE DONOR LIVER DUE TO FAILURE TO CLEAR LACTATE AND FAILURE TO MAINTAIN PH EVEN THOUGH THE FLOWS WERE FINE ONCE THE CLOT WAS REMOVED.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 19780106 ↗
• MalfunctionMay 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DEVICE USER (DU) REPORTED THAT THERE WAS A SMALL HOLE ON THE PLASTIC SIDE OF THE VASCULAR CANNULAS PACKAGING. AS ARESULT, THE ITEMS WERE DEEMED UNSTERILE AND ANOTHER ANOTHER KIT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323793 ↗
• MalfunctionMay 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE USER (DU) REPORTED THE DEVICE HAD A SMALL LEAK AT THE OXYGENATOR. A VIDEO OF THE LEAK AND ADDITIONAL PHOTOS OF THE TOP OF THE OXYGENATOR INDICATED THAT IT WAS COMPROMISED. A CLINICAL SPECIALIST (CS) ADVISED THE DU TO RESOLVE THE ISSUE BY CHANGING THE DISPOSABLE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320525 ↗
• InjuryMay 14, 2024Complete Blockage; Complete Blockage

  THE DEVICE USER REPORTED THAT MESSAGE CODE 270 (OCCLUDED TUBING) DISPLAYED ON THE DEVICE SCREEN. THE DEVICE USER WAS ABLE TO DETERMINE THAT A SYRINGE INFUSION LINE FOR HEPARIN WAS BEING OCCLUDED BY A PLASTIC FILM IN TWO LOCATIONS. THE FIRST LOCATION WAS WHERE THE TIP OF THE SYRINGE IS SCREWED INTO THE LUER LOCK. THERE WAS PLASTIC FILM THAT WAS OCCLUDING THE SYRINGE LINE FROM BEING PRIMED. THE SECOND LOCATION WAS FURTHER UP THE INFUSION LINE WHERE THE INFUSION TUBING WAS STUCK TOGETHER. IT WAS DECIDED TO DISCARD THE DONOR LIVER DUE TO LACK OF VIABILITY. THE DEVICE USER BELIEVES THAT THE OCCULDED TUBING CONTRIBUTED TO THE LIVER NOT BEING VIABLE FOR TRANSPLANTATION.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 19315704 ↗
• MalfunctionMay 13, 2024Contamination; Contamination

  IT WAS REPORTED THAT A HAIR STRAND WAS FOUND INSIDE THE STERILE PACKAGING OF ONE OF THE SILICONE BILE TUBES. IT WAS INSIDE THE SECOND PACKET, ATTACHED TO THE TUBE. THE DEVICE WAS USED DURING A TRAINING CASE SO IT WAS NOT OF CONCERN FROM A PATIENT PERSPECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307034 ↗
• MalfunctionApr 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE USER (DU) NOTICED PERFUSATE LEAKING AT THE OXYGENATOR CONNECTION. PRIMING WAS PAUSED WHILE THE CONNECTION WAS ASSESSED. DU WAS ABLE TO MANUALLY TIGHTEN THE CONNECTION WITH INITIAL RESOLUTION. PRIMING WAS THEN RESUMED BUT THE LEAK CONTINUED. THE DISPOSABLE SET WAS CHANGED. NO FURTHER ISSUE OCCURRED AFTER A NEW DISPOSABLE SET WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192139 ↗
• MalfunctionApr 25, 2024

  WHILE PREPARING THE ORGAN OX PUMP FOR LIVER DONOR ORGAN, IT WAS NOTED THAT THERE WAS A FAULTY CONNECTION FROM THE ONE TIME USE CASSETTE. A SLOW LEAK AT THE LEVEL OF THE OXYGENATOR FROM THE CANNULA ORIGINATING FROM THE LIVER BOWL NOT RESPONSIVE TO MANUAL TIGHTENING WAS DISCOVERED UPON INFUSION OF PERFUSATE. PERFUSATE WAS THEN INFUSED BACK INTO BAGS USING STERILE TECHNIQUE UNDER GRAVITY AND A NEW CASSETTE WAS INSTALLED AND CONTINUED PREP AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180738 ↗
• InjuryApr 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A SURGEON REPORTED THAT "UPON REMOVAL OF THE ARTERIAL CANNULA, THERE WAS A THROMBOSIS. THE LIVER WAS STILL TRANSPLANTED, BUT IT DID INCREASE THE TIME ON ICE BY APPROXIMATELY 30 MINUTES".

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19043401 ↗
• InjuryApr 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A SURGEON REPORTED THAT "UPON REMOVAL OF THE ARTERIAL CANNULA, THERE WAS A THROMBOSIS. THE LIVER WAS STILL TRANSPLANTED, BUT IT DID INCREASE THE TIME ON ICE BY APPROXIMATELY 30 MINUTES".

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19040953 ↗
• MalfunctionMar 20, 2024Contamination; Contamination

  THE DEVICE USER REPORTED VISUALIZING A PIECE OF HAIR IN THE CANNULA PACKAGING. A CLINICAL SPECIALIST INFORMED THE DEVICE USER TO USE A NEW SET OF CANNULAS FROM A NEW DISPOSABLE SET SO THAT THE PROCEDURE COULD BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946471 ↗
• InjuryMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A LIVER WAS PLACED ON THE DEVICE. THE DEVICE USER CONTACTED A CLINICAL SPECIALIST (CS) SUBSEQUENTLY BECAUSE A LEAK WAS OBSERVED UNDERNEATH THE LIVER BOWL APPROXIMATELY 20 MINUTES INTO THE PERFUSION. THE CS ADVISED THE DEVICE USER TO PUT BONE WAX OVER THE AREA AND REPLACE ZIP TIE ON THE CONNECTION, BUT THIS WAS UNSUCCESSFUL. ALL THE BLOOD LEAKED OUT OF THE PUMP ONTO THE DEVICE. ATTEMPT TO COLD FLUSH THE LIVER WAS UNSUCCESSFUL. DEVICE USER ALLEGED THAT THE DEVICE FAILED. LIVER WAS DISCARDED.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 18896427 ↗
• InjuryMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A LIVER WAS PLACED ON THE DEVICE. THE DEVICE USER CONTACTED A CLINICAL SPECIALIST (CS) SUBSEQUENTLY BECAUSE A LEAK WAS OBSERVED UNDERNEATH THE LIVER BOWL APPROXIMATELY 20 MINUTES INTO THE PERFUSION. THE CS ADVISED THE DEVICE USER TO PUT BONE WAX OVER THE AREA AND REPLACE ZIP TIE ON THE CONNECTION, BUT THIS WAS UNSUCCESSFUL. ALL THE BLOOD LEAKED OUT OF THE PUMP ONTO THE DEVICE. ATTEMPT TO COLD FLUSH THE LIVER WAS UNSUCCESSFUL. DEVICE USER ALLEGED THAT THE DEVICE FAILED. LIVER WAS DISCARDED.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 18894325 ↗
• InjuryMar 1, 2024Failure to Read Input Signal; Low Readings; Failure to Read Input Signal; Low Readings

  DEVICE USER REPORTED THAT THE DEVICE FAILED TO GO INTO LIVER ON BOARD MODE AFTER A DONOR LIVER WAS PLACED ON THE DEVICE. AS A RESULT, THE MARGINAL LIVER WAS DISCARDED.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 18821974 ↗