MAUDE Adverse Event Report: SUMMIT MEDICAL PRODUCTS, INC. AMBIT PIB IL PUMP; ELECTRONIC INFUSION PUMPS & SYSTEMS

Model Number 220527

Device Problem Infusion or Flow Problem (2964)

Patient Problems Blurred Vision (2137); Confusion/ Disorientation (2553)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 28-may-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

Fill volume: unknown.Flow rate: 10 ml every 3 hours.Procedure: foot fusion procedure for lisfranc (midfoot) injury.Cathplace: unknown.Date of surgery: (b)(6) 2021.It was reported the patient felt weird and was not acting 100% normal.The caller stated, "the screen now says 30 ml and when they left the hospital it said 10." the patient experienced additional symptoms which included blurred vision, confusion.The patient had paused the infusion about 10 minutes.The patient called the physician who told them to use oral pain medications to control pain but kept the pump just in case the pain got an to uncontrollable point.The pump was to initially be discontinued.

Manufacturer Narrative

The device history record for the reported lot number, f101902, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: AMBIT PIB IL PUMP
• Type of Device: ELECTRONIC INFUSION PUMPS & SYSTEMS
• Manufacturer (Section D): SUMMIT MEDICAL PRODUCTS, INC.; 504 west 8360 south; sandy UT 84070
• MDR Report Key: 11922314
• MDR Text Key: 253805818
• Report Number: 1722214-2021-00005
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00857595005824
• UDI-Public: 00857595005824
• Combination Product (y/n): N
• PMA/PMN Number: K162165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 220527
• Device Catalogue Number: N/A
• Device Lot Number: F101902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.125% BUPIVACAINE HCL.; 0.125% BUPIVACAINE HCL
• Patient Outcome(s): Other
• Patient Age: 61 YR