MAUDE Adverse Event Report: I-FLOW CORP. ON-Q C-BLOC: 400ML, 2-14 ML/HR SAF +5ML/30MIN; ELASTOMERIC PUMP

Model Number CB006

Device Problem Infusion or Flow Problem (2964)

Patient Problems Nausea (1970); Seizures (2063)

Event Date 10/09/2014

Event Type  Injury  

Event Description

Fill volume: 500 ml.Flow rate: 6 ml/hr.Procedure: right ankle tendon surgery.Cathplace; right popliteal nerve.A male pt received a popliteal block for continuous nerve block for post-op pain management.An on-q pump was started in the afternoon of (b)(6) 2014.It was reported this pump emptied in approximately 18 hrs.The pt had used the bolus dose many times.This incident was discovered on (b)(6) 2014 around 11:00 am when the pt contacted the anesthesia pa regarding his pain.He was told to increase the flow rate to 12 ml/hr, the pump was noted to be empty.The pump was removed at 11:00 am and the device discarded.It was reported the pt had felt chills, nausea, and vomiting around 9:00 am on the incident date.At round 3:00 pm on the incident date, the pt was transported to er via an ambulance as the wife reported the pt had a seizure.No further seizure activities were reported by healthcare professionals.The pt was discharged from the er after testing in stable condition and no further treatment was reported.

Manufacturer Narrative

Method: the device was reported to have been discarded, therefore an analysis cannot be conducted on the actual device.The lot number of the actual device was unk; however, the reporter gave a possible lot number of 0201234594 based on stock info.A device history record (dhr) review was performed on the possible lot number.Results: as the suspect, device and its lot number were unavailable for analysis, no testing methods were performed.For this reason results cannot be obtained.The dhr for the possible lot found that the mfg date was 12/2013 and it expires 11/30/2015.The lot met the process specifications, including quality control acceptance criteria prior to release.Conclusions: based on the use conditions of the pump, the pump was at a higher level then the infusion site at times, the pump could have ran faster than expected.The pt stated that he experienced chills, nausea and vomiting in the morning of the incident date.Shivering, nausea, and vomiting are common side effects of general anesthesia.Fever, nausea, and vomiting could also be a side effect of ropivacaine.The device was not returned to i-flow for evaluation, therefore we are unable to determine a cause for the reported event.If additional info pertinent tot his complaint is received, a follow up report will be submitted.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify and need for additional investigation.

• Brand Name: ON-Q C-BLOC: 400ML, 2-14 ML/HR SAF +5ML/30MIN
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW CORP.; irvine CA
• Manufacturer Contact: maria wagner ; a kimberly-clark health care company; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4249677
• MDR Text Key: 5109161
• Report Number: 2026095-2014-00216
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2014

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 Model Number: CB006
• Device Catalogue Number: 101347400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: DRUG: 0.2% ROPIVACAINE; B. BRAUN CATHETER
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 102