MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxicity (2333)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the actual device was not returned.As the lot number is unknown, a review of the device history record (dhr) could not b performed.Results: since 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: 500 ml, procedure: shoulder surgery, cathplace: interscalene block.It was reported that a doctor placed a catheter on a woman while on call on the night of the event.The pump clamp was originally closed, and the patient was advised to open the clamp in 8 hours to allow infusion to begin.An hour after the patient unclamped the pump, she reported symptoms which suggested local anesthetic toxicity.The patient was given direction to clamp it overnight and it would be removed at her surgeon's office in the morning.No further information is available at this time.

Manufacturer Narrative

The pump was received full.The pinch clamp was opened and the pump infused at all selectable flow rates.The tubing was cut below the blue connector to drain the medication a male and female luer were used with cyclohexanone to bond the tubing back together.A baxa repeater pump was used to refill the pump with 400ml of 0.9% saline.Flow accuracy testing was performed with the select-a-flow (saf) set to 14ml/hr and after 21.5 hours the pump yielded a flow rate of 70.7ml/hr which is within specification with a +/- 20% tolerance.Pressure pot testing was performed on the saf unit flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr without the filter.The saf unit was detached from the pump.The saf unit was connected to a pressure gauge.The average bladder pressure used was 8.35psi.The saf flow rate 2ml/hr yielded a flow rate of 2.05ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.27ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.58ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.05ml/hr which is within specifications with a +/- 20% tolerance.The evaluation summary concludes that fast flow was not observed.During the flow accuracy test, the pump met specifications.During pressure pot testing, all flow rates met specifications using the average bladder pressure.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Based on the complaint description the root cause is deemed to be unknown.The sample investigation concluded that fast flow was not observed.The sample infused at all selectable flow rates when pinch clamp was opened.Flow accuracy testing was performed and pump yielded the flow rate which was within the specification.Pressure pot testing was performed and flow rate was observed within the specification using average bladder pressure.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

Additional information received stated that the patient was fine once the pump was clamp and the catheter removed.Oral narcotics were taken to relieve the pain from the surgery.Infusion was started on (b)(6) 2017 around 5pm and ended 1 hour later.The pump was clamped and catheter removed the next day.

• Brand Name: SURGPN,400X2-14,CB SAF,-,OQ,5
• Type of Device: ELASTOMERIC - SAF
• 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: 6100586
• MDR Text Key: 59817526
• Report Number: 2026095-2016-00208
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: CB004
• Device Catalogue Number: 101347201
• Device Lot Number: 0202491501
• Other Device ID Number: 10680651134728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 0.125% BUPIVACAINE
• Patient Outcome(s): Other
• Patient Weight: 88