NA HY9M47R6Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000175634), received between Sep 25, 2019 and Jul 21, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K171308); 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 16, 2026.

Recalls naming this device

1. Oct 12, 2021Open, Classified

   Product is labeled as non-pyrogenic but endotoxin testing was not performed.

   Z-0491-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING USE, THE ENTERAL FEEDING BAG LEAKED AT THE CONNECTION NEAR THE SPIKE ADAPTER.

  Patient problems: No Information

  MAUDE report 10301849 ↗
• MalfunctionJan 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING THE FEEDING THE PATIENT WAS FAIRLY ACTIVE IN BED AND THE FEEDING SET'S TUBE BROKE CAUSING AN UNKNOWN QUANTITY OF MILK TO SPILL ON THE FLOOR AND BED. THERE WAS NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538824 ↗
• MalfunctionNov 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT WAS ON CONTINUOUS FEEDING WHEN THE FEEDS WERE FOUND TO BE LEAKING FROM A HOLE IN THE FEEDING BAG TUBING ONTO THE PATIENT'S HEATER FOR TRILOGY MACHINE AND ONTO THE FLOOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9296287 ↗
• MalfunctionSep 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT TWO DEVICES LEAKED NEAR THE BLACK RINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120351 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171308. One submission often covers many models, so check the product and lot details in each record.

• Z-0535-2018 · Jan 3, 2018 · Terminated
  Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.