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

Model Number	220527
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Blurred Vision (2137); Confusion/ Disorientation (2553)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ELECTRONIC INFUSION PUMPS & SYSTEMS
• Manufacturer (Section D): SUMMIT MEDICAL PRODUCTS, INC.; 504 west 8360 south; sandy UT 84070
• MDR Report Key: 11922314
• Report Number: 1722214-2021-00005
• Device Sequence Number: 16961249
• Product Code: FRN
• UDI-Device Identifier: 00857595005824
• UDI-Public: 00857595005824
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.125% BUPIVACAINE HCL.; 0.125% BUPIVACAINE HCL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR