MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,CB005,CBCMBO,-,OQ,5; REGIONAL ANESTHESIA PUMP KITS

Model Number CB005

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The device history record for the reported lot number,0202351423 , was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The product involved in the report has been returned and is being processed for evaluation.Upon completion of the sample evaluation; 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.This (b)(4).

Event Description

Fill volume: 500 ml, flow rate: 5 ml/hr, procedure: no surgical procedure, the patient use nerve block for knee pain - femoral block, cathplace: femoral.A report was received stating reporting a pca button was stuck in the down position.This incident happened in the hospital.There was no adverse event happened.The patient's condition was reported as stable.It is not known what type of catheter was used in conjunction with the reported pump.The yellow indicator on the ondemand unit was still at the bottom.It was reported that the button popped back up about 1-1/2 hour later after being removed from the patient.No additional information was provided.

Manufacturer Narrative

Halyard health complaint identification number was incorrectly filed in the initial report as comp-(b)(4).The correct halyard health complaint identification number is comp-(b)(4).The actual device involved in the incident was returned for evaluation.The bolus indicator received at the bottom position with the button in the upward position.The saf (select-a-flow) 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 5.01g of fluid.Bolus button testing was performed with the pressure set to 7.46psi.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 2.135g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 5.03g, all results are within specifications.The evaluation summary concludes 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.There were no kinks observed in the tubing or pump.The stuck button was not observed.No root cause was identified, sample evaluation concludes 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.There were no kinks observed in the tubing or pump.The stuck button 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 comp-(b)(4).

• Brand Name: SURGPN,CB005,CBCMBO,-,OQ,5
• Type of Device: REGIONAL ANESTHESIA PUMP KITS
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5795732
• MDR Text Key: 50412521
• Report Number: 2026095-2016-00095
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

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: 01/31/2018
• Device Model Number: CB005
• Device Catalogue Number: 101347304
• Device Lot Number: 0202351423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• 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
• Patient Age: 41 YR
• Patient Weight: 79