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

Model Number CB006

Device Problem Pumping Problem (3016)

Patient Problem Respiratory Distress (2045)

Event Date 03/11/2014

Event Type  Injury  

Event Description

Drug/diluent: 0.2% ropivacaine.Fill volume: 550ml.Flow rate: 6ml/hr.Procedure: right total knee removal and conversion right tkr.Cathplace: right thigh - adductor canal block.Date of surgery: (b)(6) 2014.It was reported by a sales rep that a pump was attached to a pt on (b)(6) 2014 after surgery.It was working well immediately after surgery and then the bolus button stopped functioning 24 hours post-op.The button would not stay down.Add'l info received per the sales rep (b)(4) 2014: it was reported that it is unk if the bolus reservoir indicator was located on the top (full) or the bottom (empty).The sample is no longer available to verify residual volume, the pt received a new pump and the defective pump was disconnected and discarded.The lot number could not be identified.It was also reported that the pt experienced an adverse event unrelated to the use of the cb006 pump.It was reported that the incident was related to the overuse of narcotics as the pt recovered after administration of narcan (an antidote to narcotic overdose).The nurse provided the incident timeline as below: (b)(6) 14:55 - infusion set at 2mls/hr post-op; (b)(6) 15:25 - infusion increased to 6mls/hr d/t anterior knee pain; (b)(6) 15:35 - respiratory code d/t narcotics - improved with narcan; infusion clamped - pt taken to icu at 16:00; (b)(6) 08:05 - infusion restarted at 2mls/hr;(b)(6) 10:08 - infusion increased to 4mls/hr; (b)(6) 11:40 - infusion increased to 6mls/hr; (b)(6) 16:30 - bolus button found to be not working properly; pump exchanged.

Manufacturer Narrative

Method: the device is not available for an eval and investigation, therefore no testing methods were performed.Results: as a lot number could not be obtained, a review of the device history record (dhr) cannot be conducted.The device was reported to have been discarded.The technical bulletin, on-q models with on demand bolus provides warning info regarding bolus activation.Conclusion: no sample was available for an eval and investigation.The sample was discarded.Without the actual product, a complete analysis cannot be conducted, therefore unable to determine a cause for the reported event.Per the medical review the pt experienced a respiratory code while connected to the pain medication pump, and the pt recovered with narcan.As respiratory distress is a potential side affect of the pain medication, i-flow was unable to obtain further pump info to rule out that the device may have caused or contributed to the event.If add'l info pertinent to this event becomes available, i-flow will submit a f/u report.

• Brand Name: ON-Q C-BLOC, 400ML, 2-14ML/HR SAF + 5 ML/30MINS
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3761093
• MDR Text Key: 4486632
• Report Number: 2026095-2014-00045
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/13/2014

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?: No
• 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: 03/13/2014
• Initial Date FDA Received: 04/10/2014
• 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: PENFIX EPIDURAL CATHETER
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 57