MAUDE Adverse Event Report: HALYARD - IRVINE HYHSURGPN,400X2-14,CB SAF,-,OQ,5; ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML

Model Number CB004

Device Problem Misconnection (1399)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device is reported to be available but has not yet been returned.The device history record for the reported lot number, 0202628360, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 30-jun-2017 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 halyard health 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 halyard health.Halyard health 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).The device was not returned.

Event Description

Fill volume: 550 ml, flow rate: 8ml/hr, procedure: left total knee replacement, cathplace: adductor canal.It was reported that there was an incident of nerve block pump misconnected to a peripheral iv catheter on the patient.The incident was discovered at 10:00pm on the evening, (b)(6) 2017.The hospital was unable to determine the cause and details of the misconnection.It was unknown when the misconnection started.The patient did not display any adverse signs or symptoms.At 11:30am on surgery day, the certified registered nurse anesthetist (crna), connected the pump to the patient in the post anesthesia care unit with flow rate set at 8ml/h.The pump has a label stating "no iv access".Additional information received 09-jun-2017 stated the iv access was in the patients left forearm.The pharmacy drained 250 milligrams from the pump.No additional information was provided.

• Brand Name: HYHSURGPN,400X2-14,CB SAF,-,OQ,5
• Type of Device: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML
• Manufacturer (Section D): HALYARD - 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, bc
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6687199
• MDR Text Key: 79249381
• Report Number: 2026095-2017-00123
• 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: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2017

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: Nurse
• Device Expiration Date: 06/21/2019
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 0202628360
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 63