MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PUMP WITH SELECT-A-FLOW/ONDEMAND 400 ML X 2-14 ML/HR + 5 ML BOLUS/30 MIN; ELASTOMERIC - COMBO

Model Number CB006

Device Problems Failure to Reset (1532); Improper Flow or Infusion (2954); Failure to Eject (4010)

Patient Problems Muscle Weakness (1967); Tachycardia (2095); Inadequate Pain Relief (2388); Numbness (2415); Alteration in Body Temperature (4568)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record is in-progress.All information reasonably known as of 05 jan 2024 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 reported event but is relaying the information 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.

Event Description

Fill volume: 545 ml.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: december 15, 2023.It was reported, the button got stuck down after the patient pressed it.It resulted in the patient being admitted to the emergency department because the drug continued to infuse, and the patient's arm went numb.Patient¿s husband cut the line to end the infusion.No medical interventions reported.Per additional information received 19dec2023, patient pushed the button and it remained stuck in push [down] position.A few minutes later, her arm was getting progressively numb and weak.Patient's husband then used scissors to cut the tubing of the pump.The catheter was removed in the emergency department around 2am.

Event Description

Procedure: right shoulder capsulorphaphy with a bone block.Cathplace: right interscalene peripheral nerve catheter.Flow rate: 6 ml/hr.Infusion stop time: (b)(6) 2023.Per additional information received on 22 jan 2024, the patient received right shoulder capsulorphaphy with a bone block ((b)(6) 2023) to treat her recurrent shoulder instability with significant glenoid bone loss.The inciting event was an initial shoulder dislocation in 2014.She received a right interscalene peripheral nerve catheter, and this was an outpatient procedure where she discharged the same morning with an on-q.That night, she pressed the demand dose button, and it stayed down, despite efforts to pry the button back up.She reported the medication ran continuously for 2-3 minutes, and her arm felt progressively numb and weak, her body felt warm, and she felt her heart rate was elevated.Attempted to pry the button up but was not successful so husband cut the line.She was brought in by ambulance on (b)(6) 2023 around 11 pm, and reported diminished sensation to right upper extremity.She was alert and oriented x4 in the emergency department (ed) and throughout her ed stay.She reported significant pain (7/10 in severity) in her right scapula and that the fingers on her right hand are not able to move as well compared to before this incident.The emergency department (ed) provider removed the catheter tip but was not able to discharge the patient due to uncontrolled pain.Anesthesia was consulted to replace the peripheral nerve catheter; this was done successfully at bedside.Patient was satisfied with the pain relief from the new onq and was discharged.On (b)(6) 2023, onq nurse called for follow-up - patient states pain is well controlled.Maintained sensation to extremity.On (b)(6) 2023, internal medicine outpatient visit about ongoing bilateral eye twitching (unrelated to onq); no concerns about onq/post-op complications mentioned.On (b)(6) 2024, sports medicine clinic visit (3 weeks post-op follow-up); surgical incision healing; slight rash which are likely related to adhesives/material from shoulder sling.No complications from surgery/onq.Fda mw report mw5150493 received on 01 feb 2024.

Manufacturer Narrative

All information reasonably known as of 15 feb 2024 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 reported event but is relaying the information 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.

Manufacturer Narrative

H6: component code: 4756 appropriate term/code not available: button.The device history record for lot 30226061 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.During flow accuracy testing, the bolus was exhibited to be in an empty position, the button was pressed and dispensed.The bolus button latched properly and dispensed the liquid, it had no issues refilling, depressing and dispensing fluid.The bolus button functioned as intended and observed no issues.During safety bolus test and bolus volume testing, results met specifications.The reported incident could not be duplicated.A root cause could not be determined.All information reasonably known as of 10 apr 2024 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 reported event but is relaying the information 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: ON-Q PUMP WITH SELECT-A-FLOW/ONDEMAND 400 ML X 2-14 ML/HR + 5 ML BOLUS/30 MIN
• Type of Device: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18455538
• MDR Text Key: 332729868
• Report Number: 2026095-2024-00004
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2024

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: CB006
• Device Catalogue Number: N/A
• Device Lot Number: 30226061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/22/2024; 03/25/2024
• Supplement Dates FDA Received: 02/15/2024; 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE HCL 0.2%
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 82 KG