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

Model Number CB006

Device Problems Mechanical Problem (1384); Device Operational Issue (2914)

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

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product has not yet been received for evaluation.The device history record for the reported lot number, 0202703667, 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 09-oct-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.(b)(4).

Event Description

Halyard received a single report that referenced two different incidents, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 2026095-2017-00178 for the second patient.Fill volume: 550 ml, procedure: interscalene, nfusion start time: (b)(6) 2017 @ 0849.It was reported that a pump had a bolus chamber that would not refill after 50 minutes.The pump and ball were connected to a patient.The bolus button was depressed once, reported to be stuck, and did not pop back up within 30 minutes.It was noted to still be stuck at 0945.The bolus button did not latch and the yellow indicator was located at the bottom position near the tubing.There were no reported consequences for the patient.

Manufacturer Narrative

The sample was received for evaluation.The pump was received full.The pinch clamp was opened and the pump infused at all selectable rates.The bolus was allowed to refill and then depressed and functioned appropriately.The tubing was cut below the blue connector to drain the medication.A male and female luer were used to bond the tubing back together using cyclohexanone.A baxa repeater pump was used to refill the pump with 400ml of 0.9% saline.Flow accuracy testing was performed with the saf¿s set to 14ml/hr.After 21.5 hours, the pump yielded a flow rate of 0.49ml/hr.This may be attributed to the bladder being filled more than once.Pressure pot testing was performed on the selected-a-flow unit flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr.The saf unit was detached from the pump.The saf unit was connected to a pressure gauge.The average bladder pressure used was 8.65psi.The saf flow rate 14ml/hr was tested first and yielded a flow rate of 3.28ml/hr, which is below specifications with a +/-20% tolerance.The filter was then remove from the tubing.Flow rate 14ml/hr without the filter yielded a flow rate of 13.15ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.29ml/hr which is with specifications with a +/- 20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.92ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 2ml/hr yielded a flow rate of 1.97ml/hr which is within specifications with a +/- 20% tolerance.Bolus button testing was performed with the pressure set to 8.65psi.The bolus was detached from the pump and the tubing was bonded back together with a male and female luer using cyclohexanone.The bolus unit was attached to the pressure gauge.The bolus button safety test results yielded an average delivery amount of 2.34g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 4.60g, all results are within specifications.The investigation summary concludes that the bolus button functioned as intended and observed no issues.Flow accuracy testing was performed and was below specification with a +/- 20% tolerance.Pressure pot testing was performed and the 2,4,8 14ml/hr rates.The 14ml/hr rate was below specification.After removing the tubing 14ml/hr and the other rates all were within specification with a +/-20% tolerance.During pca safety bolus test and bolus volume testing, results met specifications using the average bladder pressure.Destructive analysis found the pump had a slow flow due to crystalized medication in the 1ml/hr flow control tubing.Root cause could not be determined.All information reasonably known as of 13-dec-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).

• 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: 6945922
• MDR Text Key: 90406815
• Report Number: 2026095-2017-00179
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134746
• UDI-Public: 30680651134746
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

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: Health Professional
• Device Expiration Date: 04/25/2019
• Device Model Number: CB006
• Device Catalogue Number: 101347405
• Device Lot Number: 0202703667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 11/29/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR