Quantum QCD37Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05060434421838), received between Dec 15, 2022 and Jul 20, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Failure to Pump” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25868887 ↗
• MalfunctionApr 30, 2026Failure to Pump

  USER REPORTED THAT THE SYSTEM DISPLAYED POSITIVE FLOW, BUT ACTUAL FLOW WAS NOT ESTABLISHED. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043724 ↗
• MalfunctionMar 23, 2026Failure to Pump

  USER REPORTED THAT DESPITE PASSING THE PRE-BYPASS CHECKS, THE PUMP BECAME INOPERABLE WHEN GOING ON BYPASS. USER USED THE HAND-CRANK TO GENERATE FLOW AND REPLACED THE HLM WITH A BACKUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663048 ↗
• MalfunctionMar 23, 2026Failure to Pump

  USER REPORTED THAT THERE WAS NO FLOW, DESPITE SYSTEM INDICATING ACTIVE RPMS. THE USER HAD TO HAND-CRANK. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661320 ↗
• MalfunctionFeb 25, 2026Pumping Stopped

  USER REPORTED THAT AN ERROR OCCURRED WHICH ULTIMATELY RESULTS IN A PUMP STOP, REQUIRING THE USER TO HAND-CRANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443557 ↗
• MalfunctionOct 29, 2025Failure to Pump; Failure to Pump

  USER REPORTED THAT THE PUMP WOULD NOT SPIN WHEN A SETPOINT WAS SET. SPECTRUM MEDICAL CONSIDERS PUMP FAILURE TO BE A REPORTABLE EVENT; HOWEVER, THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416665 ↗
• MalfunctionSep 11, 2025Failure to Pump; Failure to Pump

  USER REPORTED THAT THE PUMP SEIZED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT AND THUS NO PATIENT HARM; HOWEVER, THIS EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025348 ↗
• MalfunctionSep 11, 2025Failure to Pump; Failure to Pump

  USER REPORTED THAT THE PUMP WOULD NOT SPIN DESPITE THE SOFTWARE SHOWING NONZERO RPM. THERE WAS NO PATIENT INVOLVEMENT AND THUS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025327 ↗
• MalfunctionSep 4, 2025Decreased Pump Speed; Decreased Pump Speed

  USER REPORTED THAT THE PUMP WOULD NOT ACHIEVE NORMAL FLOW, RESULTING IN THE USER HAND-CRANKING FOR THE CASE UNTIL NORMAL FLOW WAS ACHIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964070 ↗
• MalfunctionAug 19, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  USER REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE AND THE FLOW SUDDENLY DECREASED UNTIL THERE WAS NO FORWARD FLOW. THE USER WAS UNABLE TO CONTROL THE PUMP AND RESORTED TO HAND-CRANKING. WHILE THERE WAS NO PATIENT HARM, THIS EVENT IS CONSIDERED REPORTABLE DUE TO THE POTENTIAL FOR CAUSING PATIENT HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846561 ↗
• MalfunctionJun 19, 2025Failure to Pump; Failure to Pump

  USER REPORTED THAT THE CENTRIFUGAL PUMP DRIVER FAILED TO SPIN THE PUMP HEAD. WHILE THERE WAS NO PATIENT HARM, SPECTRUM MEDICAL CONSIDERS THIS TYPE OF EVENT TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293573 ↗
• MalfunctionApr 8, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED CENTRIFUGAL DRIVE FAILS TO ROTATE AND EMITS A NOISE WHILE TRYING TO ENGAGE. THERE WAS NO PATIENT INVOLVEMENT AND THUS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797583 ↗
• MalfunctionMar 13, 2025Noise, Audible; Noise, Audible

  DURING A CASE, THE CENTRIFUGAL PUMP CEASED OPERATION AND REQUIRED THE PERFUSIONIST TO HAND-CRANK. PERFUSIONIST SWAPPED THE CENTRIFUGAL PUMP AND THE EVENT RECURRED ON THE REPLACEMENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591653 ↗
• MalfunctionJan 31, 2025Pumping Problem; Pumping Problem

  USER REPORTED THAT THERE WAS NO FORWARD FLOW AND SOME REROGRADE AIR COMING BACK TOWARD THE ARTERIAL PUMP DURING START-UP WHEN PRIMING THE DEVICE. THE USER REBOOTED THE PUMP THEN USED IT TO SUCCESSFULLY COMPLETE THE CASE. WE CONSIDER PUMP STOPPAGES TO BE REPORTABLE. THERE WAS NO PATIENT INVOLVEMENT DURING THE PUMP STOPPAGE, AND NO HARM TO THE PATIENT WHEN THE PUMP WAS SUCCESSFULLY USED WITHIN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281183 ↗
• MalfunctionOct 23, 2024Pumping Stopped; Pumping Stopped

  ARTERIAL PUMP TILE READ "ARTERIAL HARDWARE FAULT" AND RPMS WENT TO ZERO. PERFUSIONIST NOTED ZERO FLOW AND CLAMPED LINES. CENTRIFUGAL PUMP MOVED TO HAND CRANK AND SUPPORT TO PATIENT RESUMED AFTER 1 MINUTE. DECISION MADE TO REPLACE CENTRIFUGAL PUMP DRIVE WITH NEW CP37 DRIVE AND NEW SAP CABLE. REPLACEMENT SHOWED NO SIGN OF ERROR, PUMP MOVED OVER TO NEW DRIVE FROM HAND CRANK. FLOWS RESUMED WITH NO FURTHER ALERTS ON ARTERIAL PUMP TILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513155 ↗
• MalfunctionSep 13, 2024Failure to Pump; Failure to Pump

  USER REPORTED THAT THE CP37 DRIVE UNIT WAS PRODUCING A LOUD NOISE AND APPEARED NOT TO MOVE. AFTER REPOSITIONING, THE UNIT FUNCTIONED AS INSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20210967 ↗
• MalfunctionSep 11, 2024Increase in Pressure; Increase in Pressure

  USER REPORTED THAT WHILE ON CPB, A PRESSURE SPIKE OF >350 PROGRESSING TO >400 OCCURRED. NO FLOW AT THIS POINT DUE TO PRESSURE STOP LINK. LINE TROUBLESHOOTING WAS DONE FOR KINKS AND TRIGGERED ARTERIAL OCCLUDER BUT NOTHING WAS NOTED. FLOW WAS REINSTATED WITH THE USE FOR HANDCRANKING. THE USER TRIED RECALIBRATING AND RE-ZEROING THE PRESSURE TRANSDUCER, BUT THIS DID NOT SOLVE THE ISSUE. THE PRESSURE TRANSDUCER WAS REPLACED AFTER WHICH PRESSURE WAS APPROPRIATE FOR FLOW. SURGERY WAS RESUMED AND PRESSURE WAS APPROPRIATE FOR THE REST OF THE CASE. NO HARMFUL PATIENT EFFECTS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189244 ↗
• MalfunctionDec 15, 2022Communication or Transmission Problem; Communication or Transmission Problem

  COMMUNICATION ISSUE OF CP22 MOTOR DRIVER. THE CP22 DRIVER AND CABLE WAS REPLACED AND ELIMINATED THE ISSUE. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986505 ↗