Delivery Set 16C w/ AA 35cm Line 5161102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00634624561120), received between May 26, 2022 and May 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K953838); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL BY IU HEALTH THAT A SMALL LEAK WAS NOTED ON THE DISPOSABLE, WHERE THE TUBING ENTERS THE BLOOD POUCH. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953838. One submission often covers many models, so check the product and lot details in each record.

• Z-0361-2016 · Oct 28, 2015 · Terminated
  Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7
• Z-1924-2011 · Jul 29, 2010 · Terminated
  Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure
• Z-1037-03 · May 23, 2003 · Terminated
  Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes