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 05/18/2016

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, 0202319813, 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).Device not returned.

Event Description

Fill volume: 6 ml /hr.Flow rate: 400 ml.Procedure: should arthroscopy, rotator cuff.Cathplace: regional anesthesia.A report was received stating that the on demand button was stuck and after several attempts to fix the issue the device 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 device was received with the bolus indicator 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 expense.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 8.17psi.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 2.1075g; 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 no issues were observed.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: 5737178
• MDR Text Key: 48502615
• Report Number: 2026095-2016-00076
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

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: Nurse
• Device Expiration Date: 12/31/2017
• Device Model Number: CB006
• Device Catalogue Number: 101347404
• Device Lot Number: 0202319813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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