Model Number 47177E |
Device Problem
Leak/Splash (1354)
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Patient Problem
Overdose (1988)
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Event Date 06/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that gravity set 10dp ckv 2sms dehp free roller clamp failed.The following information was provided by the initial reporter: material no.: (b)(4), batch no.: unknown.It was reported that the roller clamp failed.
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Manufacturer Narrative
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It was reported that there was a defective roller clamp.Received from the customer is one used gravity set model 47177e lot unknown.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed with the received set.Functional testing was performed by filling a lab iv bag with blue dye water and attaching it to the sets allowing fluid to flow through the whole set via gravity.Fluid flowed freely and showed no signs of leaking.During gravity testing the roller clamp was engaged and fluid flow stopped as expected.The roller clamp was engaged and disengaged multiple times.Each time the fluid flow stopped completely as intended.Device history record for model 47177e could not be performed due to no lot number being provided by customer.The customer¿s report that the roller clamp failed was not confirmed.Functional priming found no anomalies with the received set.During gravity testing the roller clamp was engaged and fluid flow stopped as expected.The roller clamp was engaged and disengaged multiple times.Each time the fluid flow stopped completely as intended.H3 other text : see h10.
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Event Description
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It was reported that gravity set 10dp ckv 2sms dehp free roller clamp failed.The following information was provided by the initial reporter: material no.: 47177e batch no.: unknown it was reported that the roller clamp failed.
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Search Alerts/Recalls
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