The user facility, (b)(6) hospital, reported the device was not allowing fluid/drugs to drip properly.The device was returned, flow rate was tested during evaluation and the complaint was not confirmed.The device was able to regulate flow consistently, turn off and run full open properly.Variation in drip rate is expected with this product.The instruction for use cautions the user that dial numbers are approximate.Medical professionals should confirm drip rate by using timer or watch with a second hand.The product specification states there must be a continuous increase in flow rate when the dial is turned from off to full.This device met specification.The complaint product was re-evaluated as part of a root cause investigation on 08 jun 2017.Engineers disassembled the item to evaluate the internal drum.The drum channel was incorrect and is being addressed with a supplier corrective action request.Based on these findings, this complaint is considered confirmed and supplier related.
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