MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PUMP WITH SELECT-A-FLOW; ELASTOMERIC - SAF

Model Number CB6004

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

Patient Problems Dyspnea (1816); Nausea (1970); Vomiting (2144); Weakness (2145); Dizziness (2194); Confusion/ Disorientation (2553)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

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 18 jul 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 halyard health complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 600 ml.Flow rate: 6 ml/hr.Procedure: right rotator cuff surgery.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the patient "had surgery yesterday [(b)(6) 2019] and home yesterday also.Stated since she had surgery feels nauseous and taking medication for nausea but doesn't seem to be helping.Also said she feels flushed but doesn't have fever but one minute is hot then cold.Also said her legs feel weak and 'like rubber.' she stated she has had these symptoms since surgery but feels like her symptoms are getting worse.Stated anxious about symptoms.Denies any other lat [latent] symptoms.No sob [shortness of breath], no metal taste in mouth but said mouth feels dry.[patient] has history of tinnitus.Does feel like she has some confusion and drowsiness.No change in bowel or bladder.No blurred vision.Pump dial is at 6ml/hr and just took po [oral] pain meds.Denies any pain at present." additional information received on (b)(6) 2019 indicated the patient was on her way to the er [emergency room].Patient's family member stated they "were not sure if patient was having a reaction to pump medication or blood clots since patient has history of blood clots." additional information received on (b)(6) 2019 indicated that the patient "went to er [previous night]and they decided that patient did have allergic reaction to pain pump.Pt [patient] stated on the way to er with pump clamped she noted she was feeling a little better.Once in er tests ran and not able to determine any cause of symptoms.They decided then to turn pump back on and within 30 minutes to one hour pt stated her symptoms returned even 'stronger' than before- nausea with vomiting, feeling week in legs and feet, slight sob ( did not have this symptom before) and dizziness.Pump re-clamped and pt stated symptoms went away within 4-5 hours.Continuing so have some pain and taking po pain meds and pain 2/10 at present.Still has catheter in place with pump clamped and rn [registered nurse] friend coming over to remove today.".

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The investigation is in progress.All information reasonably known as of (b)(6) 2019 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 halyard health 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.

Manufacturer Narrative

The actual complaint product was returned for evaluation.The pump's distal end infused when all selectable flow rates were selected during infusion verification.The flow accuracy test and pressure pot testing were performed and met specification.The functionality of the pump performed as intended.No root cause was identified.The device history record for lot 0203116058 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 2019 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 halyard health 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: ON-Q PUMP WITH SELECT-A-FLOW
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8808362
• MDR Text Key: 151623141
• Report Number: 2026095-2019-00136
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2019

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 Expiration Date: 04/21/2020
• Device Model Number: CB6004
• Device Catalogue Number: 101347603
• Device Lot Number: 0203116058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 08/16/2019; 09/19/2019
• Supplement Dates FDA Received: 09/04/2019; 09/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR
• Patient Weight: 109