MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number CB005

Device Problem Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 13-jul-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).Device not received for evaluation.

Event Description

Fill volume: 550 ml, flow rate: 4 ml/hr, procedure: rotator cuff, cathplace: unknown.It was reported by the patient's wife that the button on an elastomeric pump did not pop back up after 30 minutes during use the morning after surgery.The patient used a butter knife to get the button back to the top position.He was advised to clamp the tubing and contact the anesthesiologist.The patient's pain was noted to be a 2/10, with no ringing in the ears or metallic taste experienced.Additional information received on 29-jun-2017 from the patient's wife stated the surgery was on (b)(6) 2017 and the pump was working fine.The next day, the patient found that the bolus button was stuck.He tried to use the knife to open it, and continued to use it.The following day, the patient felt that the pump was not working because he was experiencing a lot of pain.In addition, the patient also found that his shirt was soaked and saw the blue tip of the catheter was exposed from the neck.Movement post-op was kept at a minimum.No further details available.

Manufacturer Narrative

All information reasonably known as of 13-sep-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).

Event Description

Cathplace: neck.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Type of Device: ELASTOMERIC - COMBO
• 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: 6712275
• MDR Text Key: 80259170
• Report Number: 2026095-2017-00135
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134739
• UDI-Public: 30680651134739
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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: Lay User/Patient
• Device Expiration Date: 03/13/2019
• Device Model Number: CB005
• Device Catalogue Number: 101347305
• Device Lot Number: 0202667464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR