Quantum QCD22Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05060434421821), received between Mar 29, 2024 and Mar 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Pump” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Pumping Stopped

  USER REPORTED THAT UNINTENDED PUMP STOPS WHEN FLOW WAS INCREASED TO A HIGH RPM SETPOINT. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727669 ↗
• MalfunctionMar 18, 2026Failure to Pump

  USER REPORTED STOPPED PUMP WHICH RESULTED IN HAND-CRANKING. SPECTRUM MEDICAL CONSIDERS THIS TYPE OF EVENT TO BE REPORTABLE; HOWEVER, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626501 ↗
• MalfunctionFeb 9, 2026Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information

  USER REPORTED THAT THE VV ECMO HAD SUDDENLY DROPPED TO 1 LPM (COMING FROM 3.5 LPM) WITHOUT ANY PRIOR WARNING. ICU NURSES WERE UNABLE TO INCREASE FLOW AT THE TIME OF INCIDENT. PERFUSIONIST INTERVENED, WHO WAS ABLE TO RESTORE FLOW AT APPROX 12:12. ADDITIONALLY, THE CVVH DEVICE CONNECTED ON THE CIRCUIT ALERTED FOR LOW PRESSURE. IT IS UNSURE IF THIS ALERT IS CAUSED BY THE ECMO LOW FLOW, OR VICE VERSA. VITALS APP DOES NOT SHOW ANY RPM MODULATION BASED ON EITHER PVEN OR PINT/PART.

  Patient problems: Insufficient Information

  MAUDE report 24290898 ↗
• MalfunctionOct 15, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  USER REPORTED THAT THEY WERE UNABLE TO REGULATE FLOW TO THE PATIENT AND THAT THE FLOW DID NOT MEET THE EXPECTED FLOW RATE. THE DEVICE WAS REPLACED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306970 ↗
• MalfunctionJul 30, 2025Failure to Pump; Failure to Pump

  USER REPORTED A PUMP ERROR THAT RENDERED THE PUMP INOPERABLE. THE USER RESORTED TO HAND CRANKING. THIS EVENT IS CONSIDERED REPORTABLE PER SPECTRUM MEDICAL'S CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669031 ↗
• MalfunctionJul 24, 2025Failure to Pump; Failure to Pump

  USER REPORTED AN ERROR IN WHICH THE PUMP DID NOT OPERATE AT THE CORRECT SPEED AND THEN STOPPED SPINNING ALTOGETHER. THERE WAS NO PATIENT ERROR; HOWEVER, THIS EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588090 ↗
• MalfunctionJul 2, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED A PUMP STOP DUE TO UNAVAILABLE PRESSURE MEASUREMENT. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS PUMP STOP EVENTS TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382398 ↗
• MalfunctionJan 28, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED THAT DURING A CASE THE PUMP MANAGER ALERTED FOR "NO PUMP LOCATION 12" AFTER WHICH THE USER WAS UNABLE TO CHANGE THE RPM OF THE PUMP. THE USER MADE THE DECISION TO HANDCRANK THE PUMP BEFORE HOT SWAPPING OUT THE FAULTY DRIVE TO A NEW DRIVE. THE CASE CONCLUDED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT HARM. SPECTRUM MEDICAL CONSIDERS INABILITY TO CONTROL PUMP SPEED A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251062 ↗
• MalfunctionMar 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  APPROXIMATELY 2 HOURS AFTER INITIATION OF ECMO, THE CP22 BECAME DISLODGED FROM THE DRIVE UNIT. ECMO FLOWS WERE STABLE WITHOUT ISSUE PRIOR TO THE OCCURRENCE. THE DISPOSABLE WAS IMMEDIATELY INSPECTED FOR CRACKS, AIR, COMPROMISE. NOTHING SEEN UPON VISUAL INSPECTION. THE CP22 WAS PLACED BACK IN THE DRIVE UNIT, BUT DID NOT SEEM TO BE SPINNING CORRECTLY AND A "STRANGE SOUND" WAS HEARD AT THE PUMP HEAD (NOT GRINDING). THE PRIMER ELECTED TO CHANGE OUT THE CP22 EMERGENTLY PER CENTER PROTOCOLS. THE PATIENT WAS SUPPORTED BY THE MEDICAL TEAM DURING THE INTERVENTION AND REQUIRED PRESSOR SUPPORT WITH 1 ADDITIONAL DOSE OF EPINEPHRINE. TOTAL TIME OFF BYPASS WAS 11 MINUTES. ECMO FLOW WAS RESTORED FOLLOWING THE PUMP HEAD CHANGE OUT. NO FURTHER ISSUE WITH THE PUMP HEAD/DRIVE UNIT WAS NOTED THROUGHOUT THE DURATION OF THE ECMO RUN.

  Patient problems: Reduced Blood Flow

  MAUDE report 19002374 ↗