MAUDE Adverse Event Report: HALYARD HEALTH - IRVINE ON-Q C-BLOC: 400ML, 2-14 ML/HR/ SELECT - A - FLOW; ELASTOMERIC PUMP

Model Number CB004

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

Patient Problems Headache (1880); Chills (2191); Shaking/Tremors (2515)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the actual device was received for analysis.A visual inspection was performed and a review of the device history record (dhr) was performed.Results: evaluation and investigation results will be provided once they are completed, as testing is currently in progress.Per the dhr review the lot meet manufacturing specification at release.Conclusion: once the investigation and device analysis are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending.

Event Description

It was reported that a patient experienced a reaction during infusion.The patient underwent a left rotator cuff repair, and the catheter placement was an interscalene block.The pump was infusing 0.2% ropivacaine filled to 400mls at 6ml/hr.The incident is further described as the patient developed headache, shaking, redness of face, and chills.Infusion was stopped and the symptoms subsided.The pump was not empty at the time of disconnect and available for return.The patient was reported to be in stable condition.Oct-12-2015-additional information received: the infusion was going for several hours, and around 8 pm the symptoms began.The patient took hydrocodone earlier in the day.The symptoms would come and then go away and return again.The pump was discontinued around 11 pm.It took approximately 4 hours for her to return back to her normal state.She states she is feeling fine now.

• Brand Name: ON-Q C-BLOC: 400ML, 2-14 ML/HR/ SELECT - A - FLOW
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD HEALTH - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): MARIA.WAGNER@HYH.COM; avent s. de r.l. de c.v; ave noruega edificio d-1b; fraccionamiento rubio, b.c 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5209671
• MDR Text Key: 30694227
• Report Number: 2026095-2015-00314
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2015

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: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: CB004
• Device Catalogue Number: 101347201
• Device Lot Number: 0202220395
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 49