Quantum SuperPAC CPB – 1/2 Venous with AV Bridge SPC200A-D2Recalls & reported problems
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18051160303134), received between Jun 5, 2026 and Jun 5, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Gas/Air Leak” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2026Gas/Air Leak
THE USER REPORTED THAT DURING A TRIAL, A SIGNIFICANT AIR INGRESS THROUGH THE VENOUS LINE LED TO A MASSIVE AIR LOCK WITHIN THE RESERVOIR. IN DETAIL: BYPASS WAS STARTED (SURGERY WITH COOLING TO 32 DEGREES CELCIUS). FROM THE BEGINNING: A LOT OF AIR THROUGH THE VENOUS LINE. SIGNIFICANT AIR INGRESS VIA THE VENOUS LINE. RESULTING AIR LOCK WITHIN THE RESERVOIR. AIR LOCK CAUSED SEPARATION OF THE UPPER RESERVOIR VOLUME. CONTINUOUS PUMP STOPS OCCURRED AT THE LOWER-LEVEL SENSOR DUE TO TRAPPED VOLUME IN THE UPPER RESERVOIR. SYSTEM FUNCTION WAS REPEATEDLY INTERRUPTED. MULTIPLE ATTEMPTS TO RESOLVE THE AIR LOCK WERE UNSUCCESSFUL. EVEN VACUUM APPLICATION DID NOT RESTORE FUNCTIONALITY. NO RECOVERY OF NORMAL SYSTEM OPERATION WAS POSSIBLE. AS A RESULT, QPS HAD TO BE REPLACED. NO HARM OCCURRED TO THE PATIENT. NIRS REMAINED STABLE THE WHOLE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25407818 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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