MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC PAIN RELIEF SYSTEM WITH ONDEMAND, 400 ML / 5 ML/HR + 5 ML BOLUS/60; ELASTOMERIC - ONDEMAND

Model Number	CB003
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional 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.Root cause could not be determined.All information reasonably known as of 19-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 comp-irv-17-00593.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 a halyard health product is defective or caused serious injury.
Event or Problem Description
Fill volume: 400 ml.Flow rate: unknown.Procedure: r ankle tendon repair.Cathplace: unknown.It was report that a patient experienced an on demand bolus button that was able to be pressed down, but came right back up.The orange indicator also remained at the bottom.The patient did not experience any side effects.However, the pump was clamped immediately, and the patient's wife was instructed to contact their anesthesiologist for further instructions.No further information was provided.
Additional Manufacturer Narrative
All information reasonably known as of 17-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).
Additional Manufacturer Narrative
The pump was received full.The pinch clamp was opened and infusion was observed at the distal luer.The bolus was allowed to refill and was then depressed.It functioned appropriately.The tubing was cut below the blue connector to drain the medication.A male and female luer were used with cyclohexanone to bond the tubing back together.A baxa repeater pump was used to refill the pump with 400ml of 0.9% saline.Flow accuracy testing was performed and after 60 hours the pump yielded a flow rate of 1.81ml/hr which is below specification with a +/- 15% tolerance.Pressure pot testing was performed.The tubing was detached from the pump and connected to a pressure gauge.The average bladder pressure used was 8.49 psi.After 1 hour of testing the flow rate was 4.75 which is below specifications with a +/- 15% tolerance.Pressure pot testing was performed on the glass orifice.The tubing was detached from the pump and connected to a pressure gauge.The average bladder pressure used was 8.20 psi.After 1 hour of testing the flow rate was 1.95 which is below specifications with a +/- 20% tolerance.The filter was removed from the tubing and pressure pot testing performed again.After 1 hour the glass orifice yielded a flow rate of 10.64ml/hr which is within specification with a +/-15% tolerance.Bolus button testing was performed with the pressure set to 8.49psi.The bolus unit was attached to the pressure gauge.The bolus button safety test results yielded an average delivery amount of 2.27g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 4.29g, all results are within specifications.The evaluation summary concluded that the bolus button functioned properly.The full pump infused at all selectable rates when received.After draining and then refilling the pump to nominal volume flow accuracy testing was performed with the (select-a-flow) saf set to 7ml/hr.The flow rate accuracy testing was below specification with a +/- 15% tolerance.Pressure pot testing for the selected rates were all within specification the bolus button and safety test were within specification.It was unknown how often the patient activated the bolus button.The information provided does not clarify if the product was used properly or not.An instructions for use will be provided to aid the customer in order to avoid this issue in the future.Root cause could not be determined.All information reasonably known as of 14-aug-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• Brand Name: ON-Q C-BLOC PAIN RELIEF SYSTEM WITH ONDEMAND, 400 ML / 5 ML/HR + 5 ML BOLUS/60
• Common Device Name: ELASTOMERIC - ONDEMAND
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6657827
• Report Number: 2026095-2017-00120
• Device Sequence Number: 16414035
• Product Code: MEB
• UDI-Device Identifier: 30680651134715
• UDI-Public: 30680651134715
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/21/2018
• Device Model Number: CB003
• Device Catalogue Number: 101347103
• Device Lot Number: 0202588117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 07/27/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 07/24/2017; 08/21/2017
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 122