Model Number PRI TUBING |
Device Problem
Backflow (1064)
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Patient Problem
Missed Dose (2561)
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Event Date 02/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No product will be returned per customer.The product was discarded and not returned for failure investigation.Although requested, information and race and ethnicity were not provided.
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Event Description
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It was reported that an unspecified 100ml antibiotic secondary infusion (yellow in color) back flowed into the primary bag of 500ml 0.9% sodium chloride (clear in color).The customer provided a photo of the involved products where in the primary bag of sodium chloride turned into yellowish in color.The secondary bag was empty.The patient consequently did not receive the medication dose as the clinician was unsure how much volume was actually been administered.The event occurred in pediatric medicine unit.There was no serious injury but there was a delay in infusion therapy.The physician was notified and subsequent readjustment of the medication schedule was done.
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Manufacturer Narrative
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The customer¿s report of back flow was confirmed by visual inspection of the customer-provided photo of the suspect set.Further evaluation of the photo observed that the yellow fluid flowed based the primary set¿s check valve.The root cause of this failure was not identified as no product was returned.
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Event Description
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It was reported that an unspecified 100ml antibiotic secondary infusion (yellow in color) back-flowed into the primary bag of 500ml 0.9% sodium chloride (clear in color).The customer provided a photo of the involved products where in the primary bag of sodium chloride turned into yellowish in color.The secondary bag was empty.The patient consequently did not receive the medication dose as the clinician was unsure how much volume was actually administered.The event occurred in the pediatric medicine unit.There was no serious injury but there was a delay in infusion therapy.The physician was notified and subsequent readjustment of the medication schedule was done.
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Search Alerts/Recalls
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