REPEATER H93829Recalls & reported problems
Baxter Healthcare Corporation · REPEATER Pump Universal Spike, Sterile, Luer Lock · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412476544), received between Jun 22, 2023 and Jul 7, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE VENT OF A LUER LOCK UNIVERSAL SPIKE CAME ALL THE WAY OUT, CAUSING FLUID TO LEAKED FROM THE ATTACHED BAG. THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17278791 ↗MalfunctionJun 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A LUER LOCK UNIVERSAL SPIKE WAS LEAKING. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿THE VENT CAME ALL THE WAY OUT, CAUSING FLUID TO LEAK FROM THE ATTACHED BAG¿. THE ISSUE OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17186239 ↗
Other Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.