Terumo® Advanced Perfusion System 1 806455Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00886799000878), received between Nov 26, 2018 and Jan 14, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Output Problem; Output Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE OCCLUDER HEAD WAS NOT CLAMPING DOWN ALL THE WAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154056 ↗
• MalfunctionOct 3, 2024Calibration Problem; Calibration Problem

  PER CLINICAL REVIEW: ON (B)(6) 2024, THE TEAM EXPERIENCED A PROBLEM WITH THEIR HEART LUNG MACHINE (HLM) DURING CARDIOPULMONARY BYPASS (CPB) WHEREBY THE OCCLUDER SHOWED A CALIBRATE MESSAGE. DILIGENCE FOR MORE DETAIL WAS UNSUCCESSFUL, BUT LOGS WERE PROVIDED FOR REVIEW. THE LOGS SHOWED AN UNEXPECTED STALL. THE MOST LIKELY CAUSE TO THE ISSUE WAS THAT THE USER WAS RAPIDLY PRESSING THE DOWN ARROW TO DECREASE THE FLOW PERCENTAGE AT SMALL INCREMENTS, WHICH CAUSED THE OCCLUDER TO GO 100% FLOW THEN BACK TO 68% AND LOST THE CALIBRATION. THIS SITUATION DID NOT RESULT IN A DELAY TO THE CASE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO INJURY/BLOOD LOSS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364492 ↗
• MalfunctionJun 7, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER HEAD COVER LATCH WAS POPPING OPEN. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483510 ↗
• MalfunctionMay 1, 2024Output Problem; Output Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE VENOUS OCCLUDER MODULE DISPLAYED A 'SERVICE MODULE' MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19224156 ↗
• MalfunctionNov 16, 2023Calibration Problem; Calibration Problem

  PER CLINICAL REVIEW: THE USER REPORTED AN ISSUE WITH THE HEART LUNG MACHINE (HLM) DURING CARDIOPULMONARY BYPASS (CPB). SPECIFICALLY, THE USER STATED THEY LOST CALIBRATION OF THE OCCLUDER AND THE SYSTEM WAS REQUIRING A RECALIBRATION. THEY DECIDED TO NOT USE THE OCCLUDER THE REST OF THE CASE. THE USER REPORTED NO DELAY TO THE CASE, THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM NOR BLOOD LOSS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150502 ↗
• MalfunctionAug 25, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE OCCLUDER HAD CALIBRATION ISSUES, THE PISTON WAS NOT MOVING, AND IT WAS HOT TO THE TOUCH. AS MITIGATION, THE TUBING WAS REMOVED FROM THE OCCLUDER AND THE CASE WAS COMPLETED WITHOUT IT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM EXPERIENCED AN ISSUE WITH THEIR HEART LUNG MACHINE (HLM) DURING CPB. SPECIFICALLY, WHILE PERFORMING THE PRE-BYPASS CHECKLIST THE USER NOTED THAT THE VENOUS OCCLUDER HEAD WAS HOT TO TOUCH. ADDITIONALLY, THERE WERE ISSUES WITH CALIBRATION AND THE OCCLUDER PISTON WAS NOT MOVING. THE USER TOOK THE VENOUS TUBING OUT OF THE OCCLUDER AND PROCEEDED WITHOUT IT. THERE WERE NO DELAYS TO THE PROCEDURE AND NO BLOOD LOSS NOTED. THE CASE FINISHED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624964 ↗
• MalfunctionApr 10, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER HEAD WOULD NOT CALIBRATE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709602 ↗
• MalfunctionJan 26, 2023Calibration Problem; Calibration Problem

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT THE VENOUS OCCLUDER WENT INTO CALIBRATION MODE AND COMPLETELY CLOSED, WHICH HAD TO BE OPENED BY HAND. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250335 ↗
• MalfunctionJan 11, 2023Break; Break

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE OCCLUDER HAD A CRACKED COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141341 ↗
• MalfunctionSep 24, 2022Mechanical Problem; Mechanical Problem

  PER CLINICAL REVIEW:ON (B)(6) 2022, THE TEAM EXPERIENCED A PROBLEM WITH THEIR HEART LUNG MACHINE (HLM) VENOUS OCCLUDER IMMEDIATELY PRIOR TO INITIATING CARDIOPULMONARY BYPASS (CPB), WHEREBY THE OCCLUDER WAS ALLOWING FLOW TO PASS WHEN IT WAS CLOSED ALL THE WAY. THE USER NOTICED THIS AS THE SURGEON CONNECTED THE VENOUS LINE AND REMOVED THE TUBING CLAMP AT THE FIELD, AND THE SITUATION WAS IMMEDIATELY REMEDIED BY USING A TUBING CLAMP TO CLAMP THE VENOUS LINE. THEREFORE, THERE WAS NO DELAY, NO BLOOD LOSS, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15475757 ↗
• MalfunctionAug 30, 2022Mechanical Problem; Failure to Calibrate; Mechanical Problem; Failure to Calibrate

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE OCCLUDER HEAD WOULD NOT CALIBRATE AND WAS STUCK IN THE OCCLUDING POSITION. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE END USER REPORTED THAT WHILE ATTEMPTING TO CALIBRATE THE VENOUS OCCLUDER, IT WOULD NOT CALIBRATE AND WOULD GET STUCK IN THE OCCLUDED POSITION. THIS OCCURRED DURING CPB, BUT IT DID NOT CAUSE A CASE DELAY. SUBSEQUENTLY, SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT USE OF THE OCCLUDER. AS RESULT, THERE WAS NO INJURY/BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320731 ↗
• MalfunctionJun 8, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER HEAD WAS NOT CALIBRATING. AS A RESULT AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633653 ↗
• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED THAT THE OCCLUDER HAD A BROKEN OCCLUDER END COVER. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316283 ↗
• MalfunctionJun 2, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER HEAD WOULD CLOSE BY ITSELF. THEY CONTINUED THE PROCEDURE BY OPENING THE OCCLUDER COVER AND USING MANUAL CLAMPS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM HAD AN INCIDENT WITH THE CONTROL OF THE OCCLUDER FROM THE CENTRAL CONTROL MONITOR (CCM) ON THE HEART LUNG MACHINE (HLM) DURING CPB ON (B)(6) 2021. THE TEAM CALIBRATED THE OCCLUDER PRIOR TO THE CASE. THEY INITIATED CPB WITHOUT ISSUE. THE TEAM WAS THEN ASKED TO FILL UP THE PATIENT A BIT (TRIED TO GIVE VOLUME BY OCCLUDING THE OCCLUDER A BIT ON THE VENOUS LINE). THEY TRIED TO DO THIS WITH THE SLIDER ON THE CCM AND IT WENT TO FULLY OCCLUDED. THE TEAM HAD TO MANUALLY USE CLAMPS TO PERFORM THIS COMMAND. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921306 ↗
• MalfunctionNov 20, 2020Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S CLINICAL SPECIALIST THAT THE ISSUE OCCURRED DURING PRIMING OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10874840 ↗
• MalfunctionNov 16, 2020Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S CLINICAL SPECIALIST THAT THE ISSUE OCCURRED DURING PRIMING OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10844023 ↗
• MalfunctionNov 5, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER DID NOT FULLY OCCLUDE. AS MITIGATION, MANUAL OCCLUSION WAS DONE USING FORCEPS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10795178 ↗
• MalfunctionOct 23, 2020Calibration Problem; Calibration Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE OCCLUDER HEAD WAS LOSING CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10726710 ↗
• MalfunctionMar 19, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER HEAD WOULD NOT FULLY OCCLUDE THE TUBING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9857125 ↗
• MalfunctionFeb 18, 2020Difficult to Open or Close; Difficult to Open or Close

  PER CLINICAL REVIEW: THE MANUFACTURER'S CLINICAL SPECIALIST TRIED TO GATHER ADDITIONAL INFORMATION FROM THE PERFUSIONIST REGARDING THE INCIDENT THE TEAM HAD WITH THE VENOUS OCCLUDER ON THE HEART LUNG MACHINE (HLM) DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2020. IT IS NOT KNOWN IF THE OCCLUDER WAS CALIBRATED PRIOR TO GOING ON BYPASS FOR THE PROCEDURE. THE COMPLAINT STATES THAT THE CONTROL ON THE CENTRAL CONTROL MONITOR (CCM) FOR THE OCCLUDER WAS MOVING UP AND DOWN ON ITS OWN. IT WAS NOT ABLE TO CONFIRMED OR DISCONFIRMED THAT THE ACTUAL MECHANICAL OCCLUDER WAS MIMICKING THE SOFTWARE SEEN ON THE SCREEN. ADDITIONALLY, IT WAS ASKED IF THE PERFUSIONIST WAS ABLE TO USE THE OCCLUDER, OR IF THEY REVERTED TO USING CLAMPS. THIS MITIGATION WAS NOT ANSWERED. THE TEAM DID NOT EXCHANGE THE OCCLUDER DURING THE PROCEDURE. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9723274 ↗
• MalfunctionFeb 13, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PER CLINICAL REVIEW: THE MANUFACTURER'S CLINICAL SPECIALIST TRIED TO GATHER ADDITIONAL INFORMATION FROM THE PERFUSIONIST REGARDING THE INCIDENT THE TEAM HAD WITH THE VENOUS OCCLUDER ON THE HEART LUNG MACHINE (HLM) DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2020. IT IS NOT KNOWN IF THE OCCLUDER WAS CALIBRATED PRIOR TO GOING ON BYPASS FOR THE PROCEDURE. THE COMPLAINT STATES THAT THE CONTROL ON THE CENTRAL CONTROL MONITOR (CCM) FOR THE OCCLUDER WAS MOVING UP AND DOWN ON ITS OWN. IT WAS NOT ABLE TO CONFIRMED OR DISCONFIRMED THAT THE ACTUAL MECHANICAL OCCLUDER WAS MIMICKING THE SOFTWARE SEEN ON THE SCREEN. ADDITIONALLY, IT WAS ASKED IF THE PERFUSIONIST WAS ABLE TO USE THE OCCLUDER, OR IF THEY REVERTED TO USING CLAMPS. THIS MITIGATION WAS NOT ANSWERED. THE TEAM DID NOT EXCHANGE THE OCCLUDER DURING THE PROCEDURE. THERE WAS NO DELAY IN THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9708506 ↗
• MalfunctionJan 13, 2020Calibration Problem; Calibration Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE OCCLUDER HEAD TOOK SIX TO SEVEN TIMES TO CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9581754 ↗
• MalfunctionNov 26, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER WAS NOT MOVING CORRECTLY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE TEAM SET UP THE OCCLUDER AND CALIBRATED IT WITHOUT ISSUE WITH A 1/2 BY 3/32 VENOUS LINE TUBING FOR A PROCEDURE ON (B)(6) 2018. WHEN THE TEAM ATTEMPTED TO FILL UP THE HEART DURING WEANING FROM CPB, THE PERFUSIONIST STATED THAT THE OCCLUDER DID NOT RESPOND AND CLAMPED THE LINE UNTIL IT WAS GREATER THAN 80-85% CLOSED. THIS WAS EVIDENT BY THE TEAM NOT FILLING UP THE HEART AND THE VOLUME IN THE RESERVOIR STAYING CONSTANT AND NOT REDUCING. BECAUSE OF THE RESPONSE THEY USED A REGULAR CLAMP TO FULLY COME OFF BYPASS. THE INCIDENT WITH THE OCCLUDER DID NOT DELAY THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO BLOOD LOSS OR HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8101328 ↗