MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,CB006,CBCMBO,-,OQ,5; ELASTOMERIC - COMBO

Model Number CB006

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 0202146160, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.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).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.Device not returned.

Event Description

Fill volume: 550 ml.Flow rate: unknown.Procedure: ankle surgery.Cathplace: block: saphenous block and a popliteal block.A report was received stating the bolus button of a cb006 pump did not engage and stay down.The pump continued to infuse even when the saf was set to zero.The yellow indicator on the bolus button stayed at the bottom.The pump was connected to the patient and the nurse pressed the button to deliver the first bolus.It was found to be not functioning.The patient had two blocks.It is not sure which block was the reported pump connected to when the issue was noticed.The pump was disconnected from the patient and was replaced with another pump.No additional information was provided.

Manufacturer Narrative

One sample device was returned.The original packaging was not returned with the device.The bolus indicator was received at the bottom 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 pca button was refilled to the top.The button was depressed and expensed.The bolus button latched properly and dispensed the medication, the bolus had no issues refilling.The bolus dispensed 5.02g of fluid.Bolus button testing was performed with the pressure set to 8.41psi.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 2.105g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 5.0175g, all results are within specifications.The investigation summary concluded that the bolus button functioned as intended and observed no issues.During pca safety bolus test and bolus volume testing, the results met specifications using the average bladder pressure.There were no kinks observed in the tubing or pump.The latching issue was not observed.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: SURGPN,CB006,CBCMBO,-,OQ,5
• 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: 5743408
• MDR Text Key: 48501750
• Report Number: 2026095-2016-00077
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

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: Other Health Care Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: CB006
• Device Catalogue Number: 101347403
• Device Lot Number: 0202146160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR