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

Model Number CB004

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

Patient Problems Reaction (2414); Shaking/Tremors (2515)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device was received for analysis.At this time it is currently undergoing testing.A visual inspection was performed on the returned device along with a review of the device history record (dhr).Results: at this time the evaluation is still in progress.Results will be provided once completed.The dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusion: once the investigation and device analysis are completed a follow-up report will be submitted.This incident has been included in our complaint handling database, which is actively monitored and trended.

Event Description

The patient's caretaker reported that the patient's pump was running at 8ml/hr and it was turned down (6ml/hr) because the patient's legs were shaking and the patient's legs were cramping severely.The patient also felt as if something was in her throat.A follow-up phone call was initiated after 30 minutes and it was reported that the physician advised the patient to leave the tubing clamped over night and to call the anesthesiologist in the morning.The patient had rotator cuff surgery on (b)(6) 2015.The infusion started on (b)(6) 2015 and ended on (b)(6) 2015.The pump was not empty at the time of disconnection.The symptoms appeared 4 hours after surgery while at home.The patient's symptoms dissipated after clamping the tubing.The patient's current condition was reported as stable.The device is available for return.

• Brand Name: ON-Q C-BLOC 400ML, SELECT-A-FLOW 2-14ML/HR
• Type of Device: ELASTOMERIC PUMP
• 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; fraccionamiento rubio, b.c 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5231922
• MDR Text Key: 31455409
• Report Number: 2026095-2015-00318
• 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: Patient
• Type of Report: Initial
• Report Date: 10/19/2015

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: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: 0202158151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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
• Treatment: TOPRAMAX
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 62