ambIT 220546Recalls & reported problems
Summit Medical Products, Inc. · PIB*PCA v1.5 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 00850000509023), received between Nov 7, 2024 and Nov 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Flow or 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper Flow or Infusion1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2024Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED, REGISTERED NURSE (RN) PROGRAMMED THE AMBIT PUMP (SN (B)(6), PN 220546) AS ORDERED BY THE ANESTHESIOLOGIST, WITH A DOSE 6 CC AND AN INTERVAL 120 MINUTES. A SECOND RN COMPLETED INDEPENDENT VERIFICATION OF WHAT WAS PROGRAMMED AND ATTACHED THE PUMP TO THE PERIPHERAL NERVE CATHETER AND INITIATED THE BOLUS. THE PUMP DISPLAYED 6 CC AND WAS PAUSED FOR A FEW SECONDS BEFORE BEING RELEASED. THE PUMP CONTINUED TO BOLUS BEYOND THE PRESCRIBED DOSE, IT WAS IMMEDIATELY PAUSED AGAIN, AND ANESTHESIOLOGIST WAS NOTIFIED. THE AMBIT PUMP WAS THEN DISCONNECTED FROM THE PATIENT AND UPON RELEASED FROM PAUSED AND NOTED BOLUS ADDITIONAL 6 CC OF AIR. IT DID NOT ALARM. THE DOCTORS REVIEWED THE TOTAL BOLUS AND WHAT WAS PROGRAMMED SETTINGS.
Patient problems: Insufficient Information
MAUDE report 20629224 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page