MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY S2 CONTROLLER ONLY

Catalog Number S2

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

The reported devices are being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the devices evaluation and complaint investigation.

Event Description

Upon incoming inspection the distributor reported that the s2 pumpette controllers, 30 units, were not suitable for use.The distributor found the rate not to be accurate, as the flow rate was below the printed scales.This was found before any patient contact; therefore, no patient injury was reported.This report is raised on the basis of a reported malfunction with potential for patient injury with recurrence.

Manufacturer Narrative

The devices were returned to conmed for evaluation and contained ten s2 controllers assembled to the customer's iv tube set and twenty s2 controllers were received raw.Six of the assembled devices and seven of the raw s2 controllers were randomly sampled and tested.The selected devices were tested for flow rates at the 20 ml/hr and 100 ml/hr controller dial settings.The results showed excessive variation in flow rate.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.There have been no other similar complaints for this lot product and failure mode.A two-year review of complaint history revealed 17 similar complaints, with 307 devices, for this product family and failure mode.In that same time frame, (b)(4) units were sold and shipped worldwide, making the rate of occurrence for this failure 0.122 percent.A risk analysis was performed and found this failure mode and occurrence level to be consistent and acceptable with current risk documents.The instructions for used advise and warns the user of the following.The dial numbers are approximate and confirm drip rate by using timer or watch with a second hand.An investigation has been initiated to determine the root cause for this incident.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: S2 CONTROLLER ONLY
• Type of Device: S2
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua CP 11 36; MX CP 1136
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502 ; 3156243051
• MDR Report Key: 7122047
• MDR Text Key: 95739532
• Report Number: 3007305485-2017-00281
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K905498/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: S2
• Device Lot Number: 201709244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1