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

Model Number CB004

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

Patient Problems Respiratory Distress (2045); Tinnitus (2103); Tingling (2171); Reaction (2414); Numbness (2415); Nasal Obstruction (2466)

Event Date 04/03/2015

Event Type  Injury  

Event Description

Fill volume: 540ml flow rate: 8mll/hr procedure: wrist surgery to remove bone and tendon cathplace: shoulder it was reported that a patient had a reaction while using a pump.It was reported that the patient experienced ringing in ears, numbness/tingling and a metal taste in mouth.Additional information was received on (b)(6) 2015.The patient had surgery on (b)(6) 2015.The pump infusion started at 1630.On (b)(6) 2015 at approximately 2115 the patient woke experiencing difficulty breathing and her nose was blocked.The patient also experienced numbness and tingling around her mouth.While attempting to stop the infusion, the tubing was cut and the medication leaked out.The surgeon was contacted and the patient was advised to remove the catheter.The patient's reported symptoms disappeared shortly after the pump was disconnected.No other adverse events occurred in connection with the reported incident.The sample is available for return.

Manufacturer Narrative

(b)(4).Method code: actual device not evaluated.Method: the device was reported to be returning for an evaluation and at this time is pending return.A review of the device history record (dhr) for the reported lot number was conducted.Results: at this time the investigation is still in progress.Once the device is received, device testing will be performed and results will be provided once completed.However, 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.Conclusions: 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 and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Device return anticipated.

Manufacturer Narrative

Methods: actual device was received for an evaluation and investigation.Along with the previously reported method, a visual inspection and a use review were performed.Results: a visual inspection found that the sample was received with a broken tubing at the proximal end of the select-a-flow (saf) unit and a missing clamp.The tubing was examined and found that the tubing edges indicate that a sharp object was used.The sample is unable to be evaluated due to the tubing being detached right at the proximal end of the saf unit.The tubing is unable to be bonded back together for device testing.It was reported that the anesthesiologist removed the clamp prior to the patient going home and that the patient's family member cut the tubing in error while trying to stop the infusion.Conclusions: the investigation concluded that broken tubing was observed at the proximal end of the saf unit.The device was missing the white clamp.The sample was unable to be evaluated due to the broken tubing.As it was reported, the white clamp was removed from the device by the physician prior to the patient being released home.Per the use review, the user facility did not follow the instructions for use (ifu) for removing the white clamp on the pump.The ifu (14-60-613-0-04) specifies, "caution clamp is provided to stop the infusion.Do not remove or break clamp." the ifu also specifies, "medications or fluids must be administered per instructions provided by the drug manufacturer.Physician is responsible for prescribing drug based on each patient¿s clinical status (such as age, body weight, disease state of patient, concomitant medications, etc.)." as previously reported, the device history record review indicated that the lot met the process specifications, including the quality control acceptance criteria prior to release.A technical bulletin (mk-00505) on-q with saf variable rate controller drug dosing information was sent to the customer.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): HALYARD - IRVINE; ave noruega edificio d-1b; fracc rubio; tijuana b.c. 9261 8
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4735126
• MDR Text Key: 18266051
• Report Number: 2026095-2015-00139
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2015

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: Patient Family Member or Friend
• Device Expiration Date: 04/30/2017
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: 0202026716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 04/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MARCAINE 0.25%
• Patient Outcome(s): Required Intervention