MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT CONTROLLER ONLY; CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC

Catalog Number S2

Device Problem Restricted Flow rate (1248)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This distributor reported on behalf of their customer that the s2 device had a low flow rate during pre-op testing.It was not determined if the pre-op testing occurred inside or outside the sterile field.There was no report of injury to user or any type of patient involvement.Further assessment information was requested; however, to date, no further information has been obtained.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Additional information: assessment information was obtained that states that the testing of this device was concluded in an unsterile environment.Therefore, the pre-op testing did take place outside the sterile field.Manufacturing narrative: received one s2 in opened unoriginal packaging.Was unable to verify the lot number.Performed a functional inspection using the iv stand with compressor and infuser.The flow meter was set to 100ml/ hr and we got 4 drops in 1 minute which is equivalent to 12ml/ hr.The flow meter was then set to 200ml/ hr and we got 6 drops in 1 minute.Performed a visual inspection, we disassembled the flow meter and inspected the inner drum and the drum has flashing most of the way around the channel.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 14 complaints, regarding 336 devices, for this device family and failure mode.During this same time frame 340,270 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.001.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: CONTROLLER ONLY
• Type of Device: CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 8528394
• MDR Text Key: 145371613
• Report Number: 3007305485-2019-00134
• Device Sequence Number: 1
• Product Code: LDR
• Combination Product (y/n): N
• PMA/PMN Number: K905498/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S2
• Device Lot Number: 201710205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 05/13/2019
• Patient Sequence Number: 1