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

Model Number CB004

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

Patient Problems Diarrhea (1811); Tinnitus (2103); Vomiting (2144); Chest Tightness/Pressure (2463)

Event Date 03/01/2020

Event Type  Injury  

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 20 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.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: unknown.Procedure: ankle.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported by the patient that "she was woken up in the middle of the night with ringing ears and a cold/heavy chest." patient was advised to turn dials all the way down on her saf [select-a-flow] dials and to clamp off lines immediately with white clamps on the lines and call physician/911.Additional information was received from the patient on 02-mar-2020.Patient said they called physician and he recommended they take out catheter.Catheter was removed on (b)(6) 2020.Patient is sick with diarrhea and throwing up.Patient was on the way to the er [emergency room] to be seen and unable to provide further information.

Manufacturer Narrative

All information reasonably known as of 11 may 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.

Event Description

Additional information received 07-may-2020 indicated infusion start time was (b)(6) 2020 at 1100 and infusion end time was (b)(6) 2020 at 1100."patient was in the er [emergency room] for 3 days and was tested for everything.They could not find the cause of the vomiting reason for admit.Doctor said that it was not related to the on-q, per the husband.Patient was unable to recall the pump that they had used on the patient but stated that they removed it and threw it away.".

• 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: 9864635
• MDR Text Key: 188346150
• Report Number: 2026095-2020-00041
• 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
• Report Date: 05/11/2020

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 Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other