Quantum QRP4Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05060434420794), received between Jul 26, 2024 and Feb 25, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (12 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Pumping Stopped

  USER REPORTED THAT PUMP WAS NOT ROLLING DURING PROCEDURE. THIS INTERRUPTION IN BLOOD FLOW IS CONSIDERED REPORTABLE PER SPECTRUM MEDICAL'S CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443280 ↗
• MalfunctionFeb 3, 2026Mechanical Problem

  USER CONTACTED SPECTRUM TO REPORT A FAULTY VENT PUMPT. WHEN CONNECTED TO THE FRAME, THE PUMP TILE DISPLAYED "DÉFAILLANCE MATÉRIEL" (HARDWARE FAILURE) . THE USER FIRST TESTED WITH ANOTHER CABLE, THEN TOOK THE CEREBRO PUMP AND CONNECTED IT IN PLACE OF, WHICH ALLOWED THEM TO CONTINUE THE CASE. THERE WAS NO PATIENT HARM OR DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246342 ↗
• MalfunctionDec 18, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  USER REPORTED THAT INTERMITTENT CONNECTIVITY ISSUES CAUSING THE PUMP TO STOP DURING THE PROCEDURE. THERE WAS NO PATIENT HARM; HOWEVER, UNINTENDED PUMP STOPS ARE CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838246 ↗
• MalfunctionDec 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON SITE VISIT CONFIRMED FAULTY LED ON A ROLLER PUMP, FOLLOWING A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802882 ↗
• MalfunctionDec 11, 2025Pumping Problem; Pumping Problem

  USER REPORTED THAT THE CARDIOPLEGIA PUMP DID NOT OPERATE CORRECTLY. THERE WAS NO PATIENT HARM AND THE USER RESOLVED THE ISSUE BY UNPLUGGING AND PLUGGING THE PUMP SAP CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780414 ↗
• MalfunctionOct 22, 2025Failure to Pump; Failure to Pump

  USER REPORTED THAT A PUMP SHOWED A SPEED ERROR MESSAGE AND FAILED TO ROTATE. THE USER WAS UNABLE TO TROUBLESHOOT, BEFORE SWAPPING TO A BACKUP DEVICE TO SUCCESSFULLY COMPLETE THE CASE. WE CONSIDER INABILITY TO PUMP TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355639 ↗
• MalfunctionSep 4, 2025Pumping Problem; Pumping Problem

  USER REPORTED THAT THE BOBBIN ON THE PUMP IS STRIPPED AND WOULD NOT MAINTAIN A LOCKED POSITION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964537 ↗
• MalfunctionAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING PREVENTATIVE MAINTENANCE IT NOTED THAT THE MODULE HAD AN INTERNAL CABLE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893443 ↗
• MalfunctionAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING PREVENTATIVE MAINTENANCE IT NOTED THAT THE MODULE HAD AN INTERNAL CABLE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893306 ↗
• MalfunctionAug 14, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED THAT THE BOBBIN OF THE ROLLER PUMP WAS VERY STIFF BEFORE BYPASS BUT CONTINUED TO BE USED BY TEAM. USER REPORTED THAT THEY HAD DIFFICULTY SETTING THE TUBING IN CORRECT RACEWAY DUE TO STIFF BOBBIN DURING THE CASE THE TUBING "RUCKED UP " AND SPILT CAUSING AN INTERRUPTION TO THE BLOOD FLOW. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802521 ↗
• MalfunctionJul 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED THAT LOOSE BOBBINS, WHICH PREVENTED THE PUMP FROM MAINTAINING A LOCKED POSITION. THERE WAS NO PATIENT HARM AS THE ERROR WAS IDENTIFIED DURING SET-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669015 ↗
• MalfunctionJul 17, 2025Mechanical Problem; Mechanical Problem

  DURING PREVENTATIVE MAINTENANCE, IT WAS DISCOVERED THAT THE LOCKED POSITION OF THE ROLLER PUMP DID NOT HOLD THE POSITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534677 ↗
• MalfunctionJul 16, 2025Mechanical Problem; Mechanical Problem

  USER REPORTED THAT THE BOBBIN LOCKING MECHANISM ON THE ROLLER PUMP NOT WORKING CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO RISK OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521068 ↗
• MalfunctionJun 18, 2025Pumping Stopped; Pumping Stopped

  DURING A CASE IT WAS REPORTED THAT THERE WAS A HARDWARE FAULT MESSAGE AND A FLASHING RED/YELLOW LIGHT ON THE PUMP. A BACK UP WAS USED TO COMPLETE THE CASE SUCCESSFULLY. 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 22282325 ↗
• MalfunctionJun 12, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED THAT DURING A PROCEDURE A QUANTUM ROLLER PUMP STOPPED WORKING. THE USER CHOSE TO REPLACE THE QUANTUM ROLLER PUMP. THE REST OF THE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193933 ↗
• MalfunctionMay 8, 2025Pumping Problem; Pumping Problem

  USER REPORTED PUMP FAILURE WHILE DELIVERING CARDIOPLEGIA TO PATIENT. THERE WAS NO PATIENT HARM; HOWEVER, THIS EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989371 ↗
• MalfunctionApr 28, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED ROLLER FAILURE THAT CAUSED TUBING TO BUNCH. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919228 ↗
• MalfunctionApr 23, 2025Mechanical Jam; Mechanical Jam

  USER REPORTED ROLLER PUMP JAM WHEN TRYING TO LOCK TUBING INTO PLACE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890845 ↗
• MalfunctionFeb 10, 2025Pumping Stopped; Pumping Stopped

  DURING PREVENTATIVE MAINTENANCE, IT WAS FOUND THAT THE QUANTUM ROLLER PUMP HAD AN INTERNAL CABLE ISSUE, CAUSING IT TO STOP DURING USE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344244 ↗
• MalfunctionJan 28, 2025Pumping Stopped; Pumping Stopped

  DURING A CASE THE RP (B)(6) THAT IS A CARDIOPLEGIA PUMP STOPPED TO RUN AND SHOWED THE FOLLOWING ALARM:"SPEED ERROR". THE CLINICIAN SWAPPED WITH ANOTHER 4" PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251061 ↗
• MalfunctionJan 28, 2025Pumping Stopped; Pumping Stopped

  DURING PROCEDURE, PERFUSIONIST RECEIVED A "SPEED ERROR" ALARM AND THE PUMP STOPPED. USER REPLACED THE PUMP AND THE CASE CONTINUED. THERE WAS NO PATIENT HARM. (B)(6) CONSIDERS ANY EVENT IN WHICH THE PUMP STOPS TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250216 ↗
• MalfunctionJan 15, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED THAT A ROLLER PUMP ABRUPTLY STOPPED DURING A CASE AND THE USER WAS UNABLE TO RESTART. USER REPORTED A "STRANGE NOISE" BEFORE IT STOPPED. PUMP STOP IS CONSIDERED REPORTABLE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157968 ↗
• MalfunctionDec 6, 2024Pumping Stopped; Pumping Stopped

  PERFUSIONIST REPORTED THAT A ROLLER PUMP STOPPAGE DURING A CASE. THE PERFUSIONIST USED A HAND CRANK TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER PUMP STOPPAGES TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862453 ↗
• MalfunctionDec 4, 2024Pumping Stopped; Pumping Problem; Pumping Stopped; Pumping Problem

  PERFUSIONIST REPORTED, THAT A ROLLER PUMP STOPPAGE, DURING A CASE. A BACK UP WAS USED TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER, PUMP STOPPAGES TO BE REPORTABLE. DESPITE, NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843696 ↗
• MalfunctionDec 2, 2024Pumping Problem; Pumping Problem

  PERFUSIONIST REPORTED THAT THE PUMP WOULD NOT STOP WHEN INSTRUCTED VIA THE KNOB OR TOUCHSCREEN. A BACK UP WAS USED TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER INABILITY TO CONTROL A PUMP TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20816771 ↗

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 · Completed
  Quantum 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 · Terminated
  Quantum Pump Console