MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE UNKNOWN ELASTOMERIC PUMP

Model Number UNKNOWN

Device Problem Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.All information reasonably known as of 21-feb-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 (b)(4) complaint database and identified as complaint (b)(4).The device was not returned.

Event Description

It was reported via medwatch report, mw5083010 as follows: event description: an event was reported in which an on-q pain relief system filled with bupivacaine 0.125% was connected to an iv piggy back line on an alaris primary set, ten min after the anesthesiologist has connected the on-q device, the rn realized the bupivacaine was being administered via the alaris iv set and not the sciatic nerve catheter as intended.Fortunately, the rn noticed this and reacted immediately, there was no harm to the patient.Attached are several images which show that this device has a female luer lock end that is compatible with any make luer lock ends such as an iv piggy back site.This is very troubling given events that have reported in the past related to inadvertent iv bupivacaine administration (b)(6) access number (b)(4).

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: UNKNOWN ELASTOMERIC PUMP
• 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: 8361346
• MDR Text Key: 138788278
• Report Number: 2026095-2019-00033
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1