Quantum QRP8Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05060434420770), received between May 9, 2022 and Mar 30, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (7 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K173834); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 13, 2023Completed

   The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

   Z-0224-2025 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Pumping Stopped

  USER REPORTED THAT DURING THE CASE THE PUMP SUDDENLY STOPPED. THERE WAS NO PATIENT HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728609 ↗
• MalfunctionMar 19, 2026Improper Flow or Infusion

  USER REPORTED THAT THE PUMP ROTATED IN THE REVERSE DIRECTION WHEN IT WAS SUPPOSED TO BE STOPPED. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641231 ↗
• MalfunctionMar 12, 2026Unintended Movement

  DURING PRE-INSTALLATION, A FAULTY BOBBIN LOCKING ASSEMBLY WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581641 ↗
• MalfunctionMar 6, 2026Unintended Movement

  USER REPORTED A BOBBIN ISSUE IN WHICH TUBING WAS ABLE TO SLIP WHEN BOBBINS WERE CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531084 ↗
• MalfunctionJan 9, 2026Pumping Problem

  USER REPORTED THAT THE PUMP WOULD NOT STOP AT THE END OF THE BYPASS CASE. THERE WAS NO PATIENT HARM; HOWEVER, THE USER WAS NOT ABLE TO CONTROL THE PUMP SPEED AT THIS TIME, WHICH IS CONSIDERED A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019966 ↗
• MalfunctionDec 24, 2025Failure to Read Input Signal; Insufficient Device Problem Information; Failure to Read Input Signal; Insufficient Device Problem Information

  THE USER FOUND AN ISSUE DURING BYPASS: WHILE PROTECTED MODE WAS ACTIVE, THE SYSTEM DETECTED A LOW RESERVOIR (RED LEVEL SENSOR LED OFF, ALARM DISPLAYED ON SCREEN), BUT THE PUMP DID NOT STOP AS EXPECTED. THE USER HAD TO MANUALLY SLOW THE PUMP. ACCORDING TO THE USER, THIS ISSUE IS INTERMITTENT, SOMETIMES THE PUMP STOPS AS INTENDED, AND SOMETIMES IT DOES NOT. NO HARM OCCURRED TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23887117 ↗
• MalfunctionOct 30, 2025Incorrect Measurement; Pumping Problem

  THE PERFUSIONIST REPORTED HE NOTICED THE 8" ROLLER HEAD ON THE HEART LUNG MACHINE LOSING OCCLUSION AT THE END OF THE CASE. THE FLOW PROBE WAS READING ~1L DIFFERENT THAN THE CALCULATED FLOW. THE PERFUSIONIST MADE SURE ALL OF THE SHUNTS WERE CLOSED. AFTER THE CASE, HE CHECKED OCCLUSIONS AGAIN AND FOUND ONE ROLLER WAS OFF BY 10 CLICKS AND THE OTHER WAS OFF BY 12 CLICKS. HE REPLACED THIS ROLLER WITH A BACKUP ROLLER. MANUFACTURER RESPONSE FOR ROLLER PUMP, QUANTUM PERFUSION SYSTEM (PER SITE REPORTER). COMPANY IDENTIFIED THAT AT HIGH RPM (>190), OCCLUSION LOCKING MECHANISM CAN SHIFT AFTER A HARD STOP (LID OPEN AND SAFETIES). COMPANY REPLICATED THIS ISSUE IN OTHER 8" ROLLER PUMPS. COMPANY NOTED THE EXACT RPM VARIES BY PUMP, BUT IS CONSISTENTLY 180 RPM OR HIGHER. COMPANY STATES IT WILL ASSESS SYSTEM ADJUSTMENTS TO MITIGATE THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424356 ↗
• MalfunctionOct 29, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT THE ROLLER PUMP HAD FALLING BOBBINS. BOBBIN FAILURE IS CONSIDERED A REPORTABLE EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416749 ↗
• MalfunctionOct 22, 2025Pressure Problem; Pressure Problem

  USER REPORTED A LARGE DISCREPANCY IN OCCLUDERS, WHICH AFFECTED THE PRESSURE DURING THE CASE. THIS EVENT IS CONSIDERED REPORTABLE PER SPECTRUM MEDICAL'S CRITERIA; HOWEVER, THERE WAS NO PATIENT HARM RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358315 ↗
• MalfunctionOct 20, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED THAT PUMP WOULD SUDDENLY STOP AND RESTART DURING RECIRCULATION. STOPPED PUMPS ARE CONSIDERED REPORTABLE PER SPECTRUM MEDICAL'S CRITERIA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344379 ↗
• MalfunctionAug 13, 2025Pumping Problem; Pumping Problem

  USER REPORTED A LACK OF OCCLUSION THAT RESULTED IN A DISCREPANCY IN THE MEASURED AND CALCULATED FLOW. THERE WAS NO PATIENT HARM; HOWEVER, THIS EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801076 ↗
• MalfunctionJul 18, 2025Low Readings; Low Readings

  USER REPORTED THAT THE PUMP WAS SET AND APPEARED TO BE OPERATING AT 6-7 L/MIN, BUT THE MEASURED FLOW FROM THE FLOW PROBE WAS DIFFERENT. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS THIS EVENT TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541063 ↗
• MalfunctionMay 12, 2025Naturally Worn; Naturally Worn

  DURING PREVENTIVE MAINTENANCE, A BOBBIN FAILURE WAS DISCOVERED ON THE ROLLER PUMP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001987 ↗
• MalfunctionMar 26, 2025Unintended Movement; Unintended Movement

  DURING PRE-INSTALLATION, A FAULTY BOBBIN LOCKING ASSEMBLY WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698897 ↗
• MalfunctionJan 31, 2025Pumping Stopped; Pumping Problem; Pumping Stopped; Pumping Problem

  USERS REPORTED EXPERIENCING PUMP STOP DURING A CASE. IN THESE CASES THERE WAS NO PATIENT HARM. SPECTRUM MEDICAL CONSIDERS INTERUPTION TO BLOOD FLOW A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282897 ↗
• MalfunctionDec 6, 2024Pumping Stopped; Pumping Stopped

  PERFUSIONIST REPORTED THAT A ROLLER PUMP STOPPED AND RESTARTED MULTIPLE TIMES DURING A CASE. WE CONSIDER PUMP STOPPAGES TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862619 ↗
• MalfunctionNov 28, 2024Pumping Stopped; Pumping Stopped

  PERFUSIONIST REPORTED THAT THERE WERE A NUMBER OF 2-3 SECOND INTERMITTENT STOPPAGES OF A ROLLER PUMP. THEY USED A BACK UP TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER PUMP STOPPAGES TO BE A REPORTABLE EVENT, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804881 ↗
• MalfunctionNov 19, 2024Pumping Problem; Pumping Problem

  PERFUSIONIST REPORTED RECEIVING A MOTOR FAULT ERROR DURING A CASE. A BACK UP PUMP WAS USED TO SUCCESSFULLY COMPLETE THE CASE. WE CONSIDER BLOOD FLOW INTERRUPTIONS TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20721522 ↗
• MalfunctionNov 8, 2024Pumping Stopped; Pumping Stopped

  PERFUSIONIST REPORTED MULTIPLE PUMP STOPPAGES WITHOUT ACTIVATING ALARMS. THE BACK UP PUMP WAS USED TO CONTINUE THE PROCEDURE. WE CONSIDER A PUMP STOPPAGE TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640142 ↗
• MalfunctionSep 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A CASE, THE RACEWAY RUPTURE IN THE 8INCH PUMP. THE RUPTURE RESULTED IN A SIGNIFICANT BREACH OF THE TUBING, CAUSING A MAJOR BLOOD SPILL INSIDE THE PUMP. THERE WERE NO CONSEQUENCES TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319687 ↗
• MalfunctionSep 13, 2024Pumping Stopped; Pumping Stopped

  USER REPORTED THAT DURING BYPASS, ARTERIAL ROLLER PUMP BEGAN BRIEFLY STOPPING AND RESTARTING WITHOUT ANY ERROR MESSAGES OR ALARMS. THE PERFUSIONIST CHOSE TO CONTINUE BYPASS WITH PUMP, BEHAVIOUR STOPPED OCCURRING AROUND 30 MINUTES BEFORE BYPASS WAS ENDED. PUMP WAS INSPECTED IMMEDIATELY AFTER CASE. PUMP WAS RUN AT MAX RPM, WITH AND WITHOUT TUBING, AND WITH AND WITHOUT EXTERNAL POWER. SAP CABLE WAS MANIPULATED, ROLLER HEAD WAS TURNED TO BOTH STOPS, AND LID WAS PUSHED AND OPEN/CLOSED. ERROR WAS NOT REPRODUCIBLE. OUTER CASE WAS INSPECTED FOR DAMAGE, NONE FOUND. CASE WAS REMOVED AND GROUND CLIPS INSPECTED AND APPEARED TO BE MAKING CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20210965 ↗
• MalfunctionAug 8, 2024Damaged Thread; Damaged Thread

  A TECHNICIAN REPORTED THAT DURING AN INSPECTION OF THE CENTER, HE FOUND THAT THE ROLLER PUMP (B)(6) HAS A PROBLEM WITH LOCKING OF THE BOBBINS. THE BOBBINS DO NOT LOCK ON THE SYLICON TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937834 ↗
• MalfunctionAug 8, 2024Damaged Thread; Damaged Thread

  A TECHNICIAN REPORTED THAT DURING AN INSPECTION OF THE CENTER, HE FOUND THAT THE ROLLER PUMP (B)(6) HAS A PROBLEM WITH LOCKING OF THE BOBBINS. THE BOBBINS DO NOT LOCK ON THE SYLICON TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937814 ↗
• MalfunctionMay 9, 2022Defective Component; Failure to Clean Adequately; Failure to Clean Adequately

  TUBING RUPTURE ON ARTERIAL ROLLER DURING PEDIATRIC CASE. PERFUSIONIST CHANGED OUT RACEWAY AND PLACED NEW RACEWAY INTO ROLLER. AFTER APPROXIMATELY 10 MINUTES THE NEW TUBING COULD BE SEEN WEARING AWAY IN THE RACEWAY. ROLLER PUMP SUBSEQUENTLY CHANGED OUT. LOOKING AT ROLLER PUMP PICTURES THERE APPEARS TO BE A DEFECT IN ONE OF THE ROLLERS AT THE BASE WHICH IS CIRCLED IN BLACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336921 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173834. One submission often covers many models, so check the product and lot details in each record.

• Z-2238-2019 · May 29, 2019 · Terminated
  Quantum Pump Console