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

Model Number CB004

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2019

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 0002968472 was reviewed and the product was produced according to product specifications.All information reasonably known as of 16 sep 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).[mw5088912].

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.Fda medwatch / fda user facility report # mw 5088912 received on 27-aug-2019, and the following information was provided: "the on-q pump pain relief system was inadvertently connected to the pt's hickman catheter than the right chest on-q catheter.We believe this error was due in part to the ability to easily connect the two devices.The pt's [patient's] pain control was initially provided via epidural catheter, however, following removal of the epidural catheter, the plan was to begin continuous pain relief via the on-q pain relief system.The on-q catheter was present but not visible to the nurse and had not been used up until this point.The nurse was unfamiliar with on-q pumps and assumed the on-q pain relief system should be connected to the hickman catheter.The pt received ropivacaine via the hickman times four hours before the error was identified and corrected.There was no adverse outcome as a result of this event.Our concern was the ability to easily connect the two devices." additional information received 09-sep-2019 indicated that the patient was discharged home on (b)(6) 2019.The patient did not have an adverse outcome as a result of this event; however, "our concern was the ease in which the misconnection occurred.".

• 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
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 9088190
• MDR Text Key: 159323242
• Report Number: 2026095-2019-00152
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• 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: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2019

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: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 0002968472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 62