Medline ENTR99235Recalls & reported problems
Medline Industries, Inc. · DBD-PUMP,FEEDING,ENTERAL,ENTRAFLO RNTL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277420014), received between Jul 10, 2024 and Nov 20, 2024 — classified as 1 death, 1 injury.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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
- Appropriate Device Problem Term/Code Not Available1
- Excess Flow or Over-Infusion1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Aspiration/Inhalation1
- Respiratory Failure1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
ACCORDING TO THE CUSTOMER, THE "RETAINER BRACKET WAS NOT SECURED IN THE APPROPRIATE BLUE HOLDER, TRIGGERING A FREE FLOW OF THE ISOSOURCE FEED. FREE FLOW ALARM DID NOT ENGAGE AND RESIDENT RECEIVED AN OVERFEED, WITHIN HER 1 HOUR FEED TIME."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aspiration/Inhalation
MAUDE report 20735818 ↗DeathJul 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6) 2024, "THE PATIENT WAS SUPPOSED TO GET 400ML IN 2 HRS FROM THE ENTRAFLO FEEDING PUMP. THE MACHINE WAS BEEPING AND THE NURSE RESPONDED TO THE ALARM. THE RESIDENT WAS CHECKED AT 7:50AM AND IT WAS NOTICED 1200CC WAS DELIVERED. THE BAG THAT WAS HUNG WAS 1.5L, ONLY 300ML LEFT WHEN CHECKED BY NURSE. THE RESIDENT RECEIVED 1200ML IN 90 MIN.
Patient problems: Respiratory Failure
MAUDE report 19709820 ↗
Other Pump, infusion, enteral devices
- Kangaroo 775100Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL988 reports
- Kangaroo 382400Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL677 reports
- Kangaroo 383400Cardinal Health, Inc. · Pump, Infusion, Enteral1 death659 reports
- Infinity Enteral Feeding Pump INFKIT2Zevex International, Inc. · Pump, Infusion, Enteral2 deaths407 reports
- Infinity Enteral Feeding Pump INFP01Zevex International, Inc. · Pump, Infusion, Enteral1 death207 reports
- Perfusor® 8713030UB. Braun Medical Inc. · Pump, infusion, enteral2 recalls3 deaths76 reports
- Kangaroo 775659Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL1 death139 reports
- Perfusor® 8713031UB. Braun Medical Inc. · PUMP, INFUSION, ENTERAL1 recall21 deaths87 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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