ambIT 220534Recalls & reported problems

Summit Medical Products, Inc. · PreSet PCA Pump - Green · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857595005817), received between Jun 8, 2022 and Jun 8, 2022 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Numbness1
Swelling/ Edema1

Recent adverse event reports

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

InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: TOTAL SHOULDER. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT 'STATES THAT AFTER 8-HOURS OF THE PUMP RUNNING. THE PUMP SEEMED LIKE IT WAS RUNNING TOO FAST. THE PATIENT'S ARM WAS COMPLETELY NUMB AND TINGLING...THEN IT BECAME RED AND SWOLLEN.' THE DOCTOR HAD THE FAMILY MEMBER TURN OFF THE PUMP AND REMOVE THE CATHETER FROM THE PATIENT. THE PUMP WAS DISCONTINUED WITHOUT DIFFICULTY. PATIENT CURRENTLY EXPERIENCING PAIN AT AN '8' ON THE 1-10 PAIN SCALE WITH '10' BEING THE WORST PAIN. TAKING 2 OXYCODONE TABLETS BY MOUTH EVERY 4-6 FOR PAIN CONTROL. ENCOURAGED PATIENT TO ICE SHOULDER FOR POST OP PAIN CONTROL. REDNESS, SWELLING, NUMBNESS AND TINGLING HAVE ALL RESOLVED. PATIENT DENIED EVER EXPERIENCING A FEVER, METALLIC TASTE IN THE MOUTH, OR ANY RINGING IN THE EARS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Numbness; Swelling/ Edema
MAUDE report 14635564 ↗

Device details

UDI-DI	`00857595005817`
Brand	ambIT
Model	220534
Company	Summit Medical Products, Inc.
Product code	FRN · Pump, Infusion
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.