MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X5+5,CBI,-,OQ,5; ELASTOMERIC - ONDEMAND

Model Number CBI003

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Udi # unknown.Method: the actual device was not returned.A review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.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

Fill volume: unknown, flow rate: 5 ml, procedure: total knee prosthesis with a catheter, cathplace: peripheral nervous block.A report was received from (b)(6) stating bolus button was stuck in the down position and would not pop back up after 30 minutes.The yellow mark indicator was noted to be on the bottom.No additional information was provided.

Manufacturer Narrative

Two samples were received without clear clarification which was applicable to the reported event.The samples will be identified as pump #1 and pump #2.Pump #1 lot# 0202220408 was refilled with 0.9% of saline using a 60cc syringe to 30ml.No leaks were observed during the filling process, so the pump was injected with 4ml of food grade dye.The pump was then refilled to 366ml of 0.9% saline using the baxa repeater pump.The pump was pressurized for over 48 hours and no leaks were detected.After the completion of the leak test, the button was depressed, bolus button functions properly; the bolus button latched properly and dispensed the medication.The bolus dispensed 5.02g of fluid.No issue with the functionality of the bolus was observed.There were no kinks observed in the tubing or pump.Bolus button testing was performed with the pressure set to 8.18psi.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 2.1175g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 5.0375g, all results are within specifications.Pump #2 lot#0202235367 infusion was verified when opening the pinch clamp.No leakage was observed while verifying the flow.The tubing was cut 2 inches distal to the blue connector to drain the medication.The tubing was bonded back together with a male and female luer.The pump was refilled with 0.9% of saline using a 60cc syringe to 30ml.No leaks were observed during the filling process, so the pump was injected with 4ml of food grade dye.The pump was then refilled to 366ml of 0.9% saline using the baxa repeater pump.The pump was pressurized for over 48 hours and no leaks were detected.After the completion of the leak test, the button was depressed, bolus button functions properly; the bolus button latched properly and dispensed the medication.The bolus dispensed 5.05g of fluid.No issue with the functionality of the bolus was observed.There were no kinks observed in the tubing or pump.Bolus button testing was performed with the pressure set to 8.14psi.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 2.18g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 5.0225g, all results are within specifications.The evaluation summary concludes that for pump #1 lot#0202220408 and for pump #2 lot#0202235367, leak tests were performed and observed no leaking.The bolus buttons functioned as intended and observed no issues.During pca safety bolus tests and bolus volume testing, results met specifications using the average bladder pressures.There were no kinks observed in the tubing or pumps.The latching issue and stuck button was not observed on either samples.The root cause of the reported incidents is unknown.Two pumps were returned for analysis and during evaluation no defects were found.Both pumps were analyzed for both the incidents of leaks and bolus stuck down.Both pumps met specification and no defects were found during evaluation.Review of the device history records (dhr) for the reported lot numbers identified no issues observed during the manufacturing process which would have contributed to the incident observed.In addition, the production lots met all manufacturing and quality specifications according to the dhr review.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 (b)(4).

• Brand Name: SURGPN,400X5+5,CBI,-,OQ,5
• Type of Device: ELASTOMERIC - ONDEMAND
• 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
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5857671
• MDR Text Key: 52857893
• Report Number: 2026095-2016-00110
• 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: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

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: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: CBI003
• Device Catalogue Number: 101348000
• Device Lot Number: 0202220408
• 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: 07/11/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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