MAUDE Adverse Event Report: SUMMIT MEDICAL PRODUCTS, INC. PRESET PCA PUMP; ELECTRONIC INFUSION PUMPS & SYSTEMS

Model Number	220534
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The actual device is reported to be available but has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 07-jun-2022 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).The device was not returned.
Event or Problem Description
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.
Additional Manufacturer Narrative
The device history record for the reported lot number, d829812, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The product involved in the report has been returned and was processed for evaluation.A pump and cassette was returned, the volumetric, timing, and simulated use test were within specifications.No defects noted and no alarms occurred during the test.Root cause could not be determined.All information reasonably known as of 10-nov-2022 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 21cfr803, 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: PRESET PCA PUMP
• Common Device Name: ELECTRONIC INFUSION PUMPS & SYSTEMS
• Manufacturer (Section D): SUMMIT MEDICAL PRODUCTS, INC.; 504 west 8360 south; south sandy UT 84070
• Manufacturer (Section G): PROVIDIEN DEVICE ASSMEBLY AV.; av. ferrocarril#1730 int16y17; parque industrial los pinos ii; tijuana b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14635564
• Report Number: 1722214-2022-00005
• Device Sequence Number: 17432523
• Product Code: FRN
• UDI-Device Identifier: 00857595005817
• UDI-Public: 00857595005817
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: 220534
• Device Catalogue Number: N/A
• Device Lot Number: D829812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 67 KG