ambIT* PIB-PCA Pump 220501Recalls & reported problems
Avanos Medical, Inc. · PIB-PCA Pump · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494000707), received between Jan 15, 2024 and Jan 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).
5 other recalls cover devices cleared under the same FDA submission (K162165); 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.
Reports received per month
Most reported problems
Device problems
- Excess Flow or Over-Infusion1
Patient problems
- Numbness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
ADDITIONAL INFORMATION RECEIVED ON 20-FEB-2024 STATES THAT PUMP WAS DISPOSED OF. PATIENT "SPOKE WITH HIS ANESTHESIOLOGIST AS DIRECTED; STATES AFTER DISCUSSING WITH PROVIDER, ISSUE WAS RESOLVED."
Patient problems: Numbness
MAUDE report 18510895 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162165. One submission often covers many models, so check the product and lot details in each record.
- Z-1688-2023 · Apr 24, 2023 · TerminatedambIT Cassette Filter Male Luer, Product Code: 220266
- Z-1687-2023 · Apr 24, 2023 · TerminatedSMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
- Z-1686-2023 · Apr 24, 2023 · TerminatedSMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
- Z-1685-2023 · Apr 24, 2023 · TerminatedAVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
- Z-1684-2023 · Apr 24, 2023 · TerminatedAVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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