MAUDE Adverse Event Report: I-FLOW, LLC. ON- Q C-BLOC: 400 ML, 2-14 ML/HR SELECT-A-FLOW; ELASTOMERIC PUMP, INFUSION

Model Number CB004

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

Patient Problems Dehydration (1807); Nausea (1970); Pain (1994); Vomiting (2144); Electrolyte Imbalance (2196); Inadequate Pain Relief (2388); Numbness (2415)

Event Date 07/22/2014

Event Type  Injury  

Event Description

Fill volume: 400 ml.Flow rate: 10 ml/hr (initially) then move to 12 ml/hr.Procedure: shoulder surgery.Cathplace: interscalene block.An anesthesiologist reported that pt had shoulder surgery on (b)(6) 2014 with an interscalene block.The pt was discharged home with the on-q pump.Less than 12 hours later that day, she experienced nausea and vomiting and went to ta different emergency room (er).The pt was treated for the nausea and seen by the on-call anesthesiologist to check the block due to some breakthrough pain.The anesthesiologist noted that the catheter looked fine, but the on-q pump was completely empty.The anesthesiologist then bloused the pt with local anesthetic through the catheter and her pain improved.Additional info reported by the pt on (b)(6) 2014, was that she underwent shoulder surgery with general anesthesia.The dial was set to 10 ml/hr and she reported inadequate pain relief, so the dial was turned up to 12ml/hr.After returning home from the surgery, the pt experienced nausea and vomiting.The pt reported she vomited about 30 times in 10 hours.On (b)(6) 2014 at 0200 the pt was transported to the emergency room (er) via ambulance, for severe nausea and vomiting.The pt was seen by the on-call anesthesiologist and it was noted at that time, that the pump was empty.She stated she felt numbness to her neck and face.She said she was also given iv pain medications in the er that provided adequate pain control.The pt was admitted to the hosp on the same day for severe dehydration, abnormal (low) potassium and electrolyte levels.The pt was treated with iv electrolytes (potassium).On (b)(6) 2014, the pt was discharged from the hosp and had recovered from nausea, vomiting, and dehydration.At the time of release the pt was able to tolerate oral food, but the pt continued to have pain and was treated with supplemental oral pain medications.Anp: asked not provided.

Manufacturer Narrative

Method: the device was received for an analysis.A visual inspection was performed and a review of the device history record (dhr) was conducted for the reported lot number.Results: according to the dhr review, the production lot met all mfg and qual specifications at release.At this time the evaluation is still in progress.Results will be provided once completed.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.Info from this incident will be included in our product complaint and mdr trend reporting sys.Additional investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.

• Brand Name: ON- Q C-BLOC: 400 ML, 2-14 ML/HR SELECT-A-FLOW
• Type of Device: ELASTOMERIC PUMP, INFUSION
• Manufacturer (Section D): I-FLOW, LLC.; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4101679
• MDR Text Key: 4704075
• Report Number: 2026095-2014-00156
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: 0008014440
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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: ROPIVICAINE 0.2%, GENERAL ANESTHESIA; BRAUN CATHETER
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 49 YR