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

Model Number CB006

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

Patient Problem Pain (1994)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record for the lot number, 0202372913, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was returned.The original packaging was not returned with the device.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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 500 ml.Flow rate: 5 ml/hr to 6ml/hr.Procedure: total knee replacement.Cathplace: femoral nerve block.Pump start time: (b)(6) 2016 at 1415pm.Pump end time: (b)(6) 2016 at 0849am a report was received stating the hospital pharmacy technician had an ondemand pump in which the bolus button would not latch with the yellow button on the bottom.The ondemand unit had worked the first time when the nurse pressed the button for the first time.The clinicians noticed the incident when the patient started to hurt and could not use the ondemand unit.The ondemand unit was set at 6ml per hour.At the time when the incident was noticed, the pump was still quite full.A broken red key remnant was not noticed inside the bolus button.The pump was disconnected from the patient and a new pump was connected.There was no reported patient injury reported.

Manufacturer Narrative

The actual complaint sample 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 8.16psi.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 2.115g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 5.0275g, 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 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.The root cause of the reported incident is unknown.The pump was returned for analysis and the pump met all specifications during sample evaluation testing.The investigation concluded that the bolus button functioned as intended and no defects were observed.Review of the device history record (dhr) identified no issues observed during the manufacturing process which would have contributed to the incident observed.According to the dhr review, the production lot met all manufacturing and quality specifications.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.

• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5906478
• MDR Text Key: 54083889
• Report Number: 2026095-2016-00127
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2016

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: 02/28/2018
• Device Model Number: CB006
• Device Catalogue Number: 101347404
• Device Lot Number: 0202372913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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