Quantum QRP6Recalls & reported problems
Spectrum Medical Limited · Quantum Roller Pump - 6 inch · Class 2
Quick summary
This Quantum QRP6 is a roller pump head used in heart-lung machines during cardiopulmonary bypass surgery. Most of the 72 reports describe the pump stopping or failing to spin during a procedure, going offline or showing speed error messages, and moving when it was not supposed to; some mention damaged threads and mechanical wear. None of the reports describe deaths or injuries. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 05060434420787), received between Oct 19, 2021 and Jul 3, 2026 — classified as 66 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (31 reports).
2 other recalls 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.
Reports received per month
Most reported problems
Device problems
- Unintended Movement31
- Pumping Stopped12
- Pumping Problem8
- Damaged Thread5
- Failure to Pump3
- Mechanical Problem3
- Excess Flow or Over-Infusion1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions66
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2026Pumping Stopped
THE USER REPORTED PUMP ISSUE DURING PROCEDURE: THE PUMP DID NOT SPIN AND SHOWED A PUMP SPEED ERROR. A RESET AND LOOSENING OF OCCLUSION WAS TRIED SEVERAL TIMES WITHOUT SUCCESS. THE PUMP ALSO WENT OFFLINE SEVERAL TIMES. NO CONSEQUENCES OCCURRED TO THE PATIENT OF FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25701374 ↗MalfunctionMar 12, 2026Unintended Movement
BOBBIN FAILURE IDENTIFIED DURING PREVENTIVE MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580702 ↗MalfunctionMar 12, 2026Unintended Movement
BOBBIN FAILURE IDENTIFIED DURING PREVENTIVE MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580591 ↗MalfunctionMar 12, 2026Unintended Movement
USER REPORTED THE BOBBINS ON THE ROLLER PUMP HAS BECOME LOOSE. THE BOBBINS DID NOT HOLD THEIR POSITION DESPITE BEING IN THE LOCKED POSITION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579300 ↗MalfunctionMar 12, 2026Unintended Movement
SERVICE ENGINEER COMPLETED A PAWL & RATCHET REPLACEMENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579267 ↗MalfunctionMar 12, 2026Unintended Movement
SERVICE ENGINEER COMPLETED A PAWL & RATCHET REPLACEMENT AND NOTED BOBBIN WAS EXTREMELY LOOSE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579252 ↗MalfunctionMar 12, 2026Unintended Movement
SERVICE ENGINEER IDENTIFIED A FAULTY BOBBIN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579232 ↗MalfunctionMar 12, 2026Unintended Movement
BOBBIN FAILURE IDENTIFIED DURING PREVENTIVE MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578448 ↗MalfunctionMar 12, 2026Unintended Movement
BOBBIN FAILURE IDENTIFIED DURING PREVENTIVE MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578447 ↗MalfunctionMar 12, 2026Unintended Movement
BOBBIN FAILURE IDENTIFIED DURING PREVENTIVE MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578425 ↗MalfunctionMar 12, 2026Unintended Movement
DURING A CASE, A ROLLER PUMP HAD A BOBBIN THAT LOOSENED WHILE LOCKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578317 ↗MalfunctionMar 12, 2026Unintended Movement
DURING PRE-INSTALLATION, THE BOBBINS WERE FOUND TO BE SLIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578301 ↗MalfunctionMar 11, 2026Unintended Movement
USER REPORTED THAT ONE OF THE ROLLERS HAD BOBBINS THAT WOULD LOOSEN WHEN THE LEVER WAS IN THE LOCKED POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24573892 ↗MalfunctionMar 11, 2026Unintended Movement
DURING PRE-INSTALLATION, THE BOBBINS WERE FOUND TO BE SLIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566544 ↗MalfunctionMar 11, 2026Unintended Movement
BOBBIN WOULD NOT REMAIN LOCKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566540 ↗MalfunctionMar 9, 2026Unintended Movement
USER REPORTED THAT THEY WERE UNABLE TO PROPERLY LOAD TUBING IN THE RACEWAY DUE TO THE BOBBINS NOT RATCHETING ON THE LEFT SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545513 ↗MalfunctionMar 9, 2026Unintended Movement
IT WAS DISCOVERED THAT WITH THE BOBBIN LOCKED, THE BOBBINS STILL SPIN TO OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545191 ↗MalfunctionMar 9, 2026Unintended Movement
IT WAS DISCOVERED THAT WITH THE BOBBIN LOCKED, THE BOBBINS STILL SPIN TO OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544862 ↗MalfunctionMar 9, 2026Unintended Movement
IT WAS DISCOVERED THAT WITH THE BOBBIN LOCKED, THE BOBBINS STILL SPIN TO OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544608 ↗MalfunctionMar 9, 2026Unintended Movement
USER REPORTED THAT THE BOBBINS NO LONGER LOCK WHEN THE FLAG IS IN THE CLOSED POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543685 ↗MalfunctionMar 6, 2026Unintended Movement
USER REPORTED THAT THE BOBBIN NO LONGER LOCKS WHEN THE FLAG IS IN THE CLOSED POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530684 ↗MalfunctionMar 6, 2026Unintended Movement
USER REPORTED THAT THE BOBBIN WOULD NOT REMAIN IN POSITION WHEN RATCHETED, WHICH CAUSED THE TUBING TO SLIP. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530634 ↗MalfunctionMar 6, 2026Unintended Movement
SERVICE ENGINEER IDENTIFIED A FAULTY BOBBIN ON TWO ROLLER PUMPS, WHICH CAUSED THE TUBING TO SLIP FROM POSITION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530627 ↗MalfunctionMar 6, 2026Unintended Movement
DURING PREVENTATIVE MAINTENANCE, IT WAS DISCOVERED THAT THE BOBBINS WERE LOOSE AND INSTALLED BACKWARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530607 ↗MalfunctionMar 6, 2026Unintended Movement
BOBBIN FAILURE IDENTIFIED DURING PREVENTIVE MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530567 ↗
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-0224-2025 · Mar 13, 2023 · CompletedQuantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-0000
- Z-2238-2019 · May 29, 2019 · TerminatedQuantum Pump Console
Other Console, Heart-Lung Machine, Cardiopulmonary Bypass devices
- Terumo® Advanced Perfusion System 1 801188Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass3 recalls447 reports
- MAQUET CARDIOHELP CARDIOHELP-iMaquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS5 recalls2 deaths64 reports
- MAQUET CARDIOHELP CARDIOHELP SystemMaquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS4 recalls18 deaths107 reports
- Terumo® Advanced Perfusion System 1 816300Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass300 reports
- Terumo® Advanced Perfusion System 1 816571Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass230 reports
- Terumo® Advanced Perfusion System 1 801763Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 death230 reports
- ESSENZ HLMLivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall1 death110 reports
- Terumo® Advanced Perfusion System 1 5773Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 recall78 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.