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

Model Number CB004-N

Device Problem Insufficient Information (3190)

Patient Problems Dizziness (2194); No Code Available (3191)

Event Date 01/31/2020

Event Type  malfunction  

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 20 feb 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 inc.Complaint database and identified as complaint (b)(4).

Event Description

Fill volume: unknown flow rate: 8 ml/hr procedure: right total knee cathplace: unknown infusion start time: (b)(6) 2020.Infusion stop time: (b)(6) 2020.It was reported that the patient has dizziness since he was in the hospital.Patient takes xanax and trazadome to sleep.Sleeping, dizzy, melancholy since he woke up this morning, slurred speech while on the phone.Not taking aspirin as prescribed and has only taken tylenol for pain.Additional information obtained from the patient at 1830 on 31-jan-2020 indicated that the pump had been removed since 1530.Patient is starting to feel better and "more like himself." pump was placed on (b)(6) 2020 and was empty by (b)(6) 2020 when it was removed.Patient received a bolus.Pump was carried "in bag." pump was not under a warming/cooling device.Select a flow dial was not changed.

Manufacturer Narrative

The device history record for lot 0002976705 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The pump functioned as intended; flow accuracy and pressure pot testing were performed obtaining results within specifications.Root cause could not be determined.All information reasonably known as of 16 apr 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 inc.Complaint database and identified as complaint comp-ghc-20-00363.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 product involved in the report has been returned and is being processed for evaluation.The investigation remains in progress.All information reasonably known as of 25 mar 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 inc.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: 9734896
• MDR Text Key: 206132102
• Report Number: 2026095-2020-00028
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2021
• Device Model Number: CB004-N
• Device Catalogue Number: 104493001
• Device Lot Number: 0002976705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2020
• Patient Sequence Number: 1
• Treatment: TRAZADONE; TYLENOL; XANAX
• Patient Age: 72 YR
• Patient Weight: 65