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.
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The devices were returned to conmed for evaluation and it 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 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, below and above the set 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 327 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 0.191 percent.A risk analysis was performed and found this failure mode and occurrence level to be consistent 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.This issue will continue to be monitored through the complaint system to assure patient safety.
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