MPS 3 Delivery Set w/AA w/106cm (16C) 5163103Recalls & reported problems
Quest Medical Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00634624500341), received between Jun 6, 2022 and Jun 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood 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.
Most reported problems
Device problems
- Fluid/Blood 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.
MalfunctionJun 6, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TO QUEST MEDICAL THAT AN MPS DELIVERY SET WAS ALLEGEDLY LEAKING AT THE INLET OF THE BLOOD CASSETTE. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14605772 ↗
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- Heater-Cooler System 3T 208V ~ / 60HzLivaNova Deutschland GmbH · Controller, temperature, cardiopulmonary bypass34 reports
- MPS 3 Delivery Set w/AA w/305cm Line (16C) 5163102Quest Medical Inc · Controller, Temperature, Cardiopulmonary Bypass3 reports
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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