MAUDE Adverse Event Report: AVANOS - IRVINE UNKNOWN ELASTOMERIC PUMP; REGIONAL ANESTHESIA

Model Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problems Stacking Breaths (1593); Tinnitus (2103); Tingling (2171)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 07-nov-2018 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).

Event Description

Fill volume: unknown, flow rate: 6 ml/hr, adjusted to 4 ml/hr, procedure: shoulder surgery, cathplace: interscalene.It was reported that a patient had an interscalene block.The patient's husband reported that his wife felt nauseated and generally felt "off".He stated that he had to help her walk around the house because she had tingling sensations in her feet and otherwise felt weak.The husband turned down the flow rate from 6 ml/hr to 4 ml/hr and the pump was clamped.The patient also had to take deeper breaths.The patient's color was noted as good, normal for her and the breathing was not bad, just noted to be a bit harder to breathe.The patient had a "little bit" of ringing in the ears and denied heart palpitations or racing heart beat.The patient stated both her feet were tingling.The patient was instructed to keep the pump clamped until they confer with the anesthesiologist as it was unable to be determined if the pump was supplying too much medicine even though it was set at safe rate.Additional information has been requested but not yet received.

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson 85756
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta 30004 ; 4704485444
• MDR Report Key: 8086663
• MDR Text Key: 129313617
• Report Number: 3006646024-2018-00037
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1