MAUDE Adverse Event Report: AVANOS MEDICAL INC. AMBIT PIB-PCA PUMP; ELECTRONIC INFUSION PUMPS & SYSTEMS

Model Number 220501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Red Eye(s) (2038); Hot Flashes/Flushes (2153); Dizziness (2194); Sweating (2444); No Code Available (3191)

Event Date 09/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 30 sep 2020 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported that a (b)(6) year old healthy patient experienced symptoms of redness of the left eye, nausea, sweating, and felt hot, lightheaded, and dizzy, after placement of an ambit pib-pca following a procedure on the left shoulder.The procedure occurred on (b)(6) 2020 and ended at 11am.On an unknown date post procedure, the patient went to physical therapy and began experiencing dizziness, but felt better soon after.On (b)(6) 2020, the patient experienced the described symptoms (redness of the left eye, nausea, sweating, and felt hot, lightheaded, and dizzy).The patient's mother called the manufacturer hotline to report, and was advised to clamp off the catheter and call the anesthesiologist immediately.Upon follow up, the patient's mother reported that the patient was instructed to discontinue use of the pump.Five minutes after removal of the pump, the patient's symptoms resolved.No additional intervention was required.The physician believes the patient's symptoms were caused by the medication leaking onto the nerve that innervates the eye.No further information provided at this time.

Manufacturer Narrative

The device history record for lot e934401 was reviewed and the product was produced according to product specifications.All information reasonably known as of 30 nov 2020 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 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: AMBIT PIB-PCA PUMP
• Type of Device: ELECTRONIC INFUSION PUMPS & SYSTEMS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10608376
• MDR Text Key: 209238080
• Report Number: 1722214-2020-00005
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00857595005688
• UDI-Public: 00857595005688
• Combination Product (y/n): N
• PMA/PMN Number: K162165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 220501
• Device Catalogue Number: N/A
• Device Lot Number: E934401
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR