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

Model Number CB6004

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Abdominal Pain (1685); Aneurysm (1708); Chest Pain (1776); Seizures (2063); Numbness (2415)

Event Date 06/03/2019

Event Type  malfunction  

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 not possible as no lot number was provided.All information reasonably known as of 24 jun 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).

Event Description

Fill volume: unknown, flow rate: 2 ml/hr, procedure: fascia iliaca block, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that a patient "went to the er [emergency room] with numbness in the mouth, pains in the chest, and a seizure." the pump was "installed on monday, er doc [doctor] said the pump was empty.Anesthesiologist said he set flow rate at 2ml/hr, ok¿d patient to adjust to 14 immediately following pt [physical therapy] then he would turn it back down".Additional information received from the physician on 12-jun-2019 indicated the patient is in stable condition."patient presented to er with oral numbness, chest pain, abdominal pain, and a triple aaa [abdominal aortic aneurysm].States medication was bupivacaine and the patient was a known opioid abuser, and was experiencing relief until the symptoms he experienced when he presented at er." "states patient was treated successfully with lipids.States he started patient on 2 cc/hr and told the patient he could turn up to 14 cc/hr when doing pt, and when done pt could turn back down.Physician states when patient presented to er, patient told them he had the pump at 2 cc/hr.Physician states he has been using pumps 'for a long time' and usually uses 1/4% but this time it was.125.States moving forward will resume at 1/4%".

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.The investigation is in progress.All information reasonably known as of 23 jul 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 device history record for lot 0002975510 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.All tested rates met specification with a +/- 20 tolerance.The device functioned as intended; no fast flow was observed.Root cause could not be determined.All information reasonably known as of 21 aug 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 INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8730332
• MDR Text Key: 149204706
• Report Number: 2026095-2019-00123
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2021
• Device Model Number: CB6004
• Device Catalogue Number: 101347600
• Device Lot Number: 0002975510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2019
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 109