MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C BLOC: 400 ML, 2-14 ML/HR SELECT-A-FLOW +5 ML/30MIN ONDEMAND; ELASTOMERIC - COMBO

Model Number CB006

Device Problems Sticking (1597); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The device history record for the lot number, 0202414324, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The product involved in the report has been returned and is being processed for evaluation.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.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

A report was received stating that a nurse on the unit tried to attach the pump to the patient.However, the nurse noticed that the pca button could not be depressed.The pca reservoir was empty and the indicator on the bottom.It was also noted that there were three kinks in the pump's tubing above the saf unit.The pump was returned to the pharmacy.When the pharmacist attempted to dial the saf to 14ml, the pump flowed.When it was dialed back to 0, the pump did not flow.It was noted that there was no broken red tab inside the on demand unit.͊ the pump was not used on a patient and there was no associated adverse event.

Manufacturer Narrative

One sample device was returned.The original packaging was not returned with the device.The bolus indicator received at the top position with the button in the upward position.The saf flow rates were verified for infusion.All the flow rates flowed except 0ml/hr.The button was depressed and expensed.The bolus button latched properly and dispensed the medication, the bolus had no issues refilling.The bolus dispensed 5.03g of fluid.Bolus button testing was performed with the pressure set to 8.75psi.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 2.1125g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 5.0475g, all results are within specifications.Destructive analysis was performed on the pca unit to examine the internal components for excessive adhesive.The pca unit was examined under a microscope magnified at 2x, no indication of excessive adhesive was observed.The pump was examined for kinked tubing.Multiple kinks were observed throughout the pump.The investigation summary concluded that the bolus button functioned as intended and observed no issues.During pca safety bolus test and bolus volume testing, results met specifications using the average bladder pressure.Multiple kinks were observed throughout the pump.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: 400 ML, 2-14 ML/HR SELECT-A-FLOW +5 ML/30MIN 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, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5935491
• MDR Text Key: 54656908
• Report Number: 2026095-2016-00138
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

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: Pharmacist
• Device Expiration Date: 03/31/2018
• Device Model Number: CB006
• Device Catalogue Number: 101347404
• Device Lot Number: 0202414324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1