ambIT 220501YRecalls & reported problems

Summit Medical Products, Inc. · Yellow PIB*PCA Pump · Class 2

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 00857595005695), received between Sep 30, 2020 and Sep 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Infusion or Flow Problem1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2020Infusion or Flow Problem; Infusion or Flow Problem
FILL VOLUME: UNKNOWN. FLOW RATE: 10ML BOLUS IN PIB SETTING. PROCEDURE: NERVE BLOCK. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT , "THE DOCTOR WAS DEMONSTRATING THE PUMP TO NURSING STAFF. THE DOCTOR INITIATED A 10ML BOLUS AND HE BELIEVES THE PUMP CONTINUED TO RUN BEYOND THE EXPECTED PERIOD. THE DOCTOR REMOVED THE PUMP FROM THE PATIENT AND BELIEVES THE PUMP ENDED UP DELIVERING 20MLS. DOCTOR INFORMS THERE WAS NO ADVERSE IMPACT ON THE PATIENT." THE DISTRIBUTOR PICKED UP THE PUMP AND STATED THE PUMP PRESCRIPTION AND HISTORY READINGS STATE IT IS SET UP FOR PROGRAMMABLE INTERMITTENT BOLUS (PIB) FOR 10MLS EVERY 3 HOURS AND THAT THE PUMP HAS RUN FOR 7 HOURS 38 MINUTES AND DELIVERED 20MLS. THE DISTRIBUTOR LET THE PUMP RUN TO ITS NEXT BOLUS DELIVERY POINT AND MEASURED THE OUTPUT USING A MANUAL MEASURING DEVICE; THE PUMP ACCURATELY DELIVERED 10MLS EVERY 3 HOURS. THE PUMP WAS INFUSING 0.2% ROPIVACAINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10607529 ↗

Device details

UDI-DI	`00857595005695`
Brand	ambIT
Model	220501Y
Company	Summit Medical Products, Inc.
Product code	MEA · Pump, Infusion, Pca
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Aug 7, 2024

Device type (GMDN): Ambulatory non-insulin infusion pump, electronic

A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.