PRODUCT CODE FRN
Pump, Infusion
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Death reports · review source evidence. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
12,304Prior 90 days: 14,437Injury reports
201Source-classified event typeDeath reports
24Reported relationship is unverifiedReporting change
-14.8%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 11,932. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
Alaris System
Read FDA report 50515254 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Circuit Failure
Alaris System
Read FDA report 50515255 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Use of Device Problem
Alaris System
Read FDA report 50515256 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Use of Device Problem
Alaris System
Read FDA report 50515257 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Use of Device Problem
Alaris System
Read FDA report 50515258 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Use of Device Problem
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.