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Model Number PRI TUBING |
Device Problems
Fluid/Blood Leak (1250); Material Separation (1562)
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Patient Problem
Death (1802)
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Event Date 09/10/2019 |
Event Type
Death
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Manufacturer Narrative
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The customer¿s report of separated and leaked from the blue safety clamp was confirmed.Received from the customer was one partial primary set that was not able to be identified.The received partial set consisted of the tubing and components from the lower fitment and below.Visual inspection of the partial set found the set was received with a small portion of the silicone pump segment attached to the lower fitment.The ring retainer was still attached to the lower fitment.Inspection of the tear under a lab microscope observed the tear to be jagged.No tool marks were observed.No crush marks were observed on the lower fitment.No functional testing could be performed due to the tear in the silicone pump segment and the obvious leaking that would occur.Functional testing of the new unopened primary sets did not observe or replicate any leaks or tear damage.The source of the leak was due tear damage in the silicone pump segment near the upper fitment.The root cause of the tear damage could not be determined.Note: the customer sent a partial tubing set that was not able to be identified, however, the customer also sent one unused/unopened sample of tubing set material number 2420-0007, lot number 19023002 and one unused/unopened sample of tubing set material number 2420-0007, lot number 18073054.Section a.Demographics were requested, however not provided.The customer stated that the patient was an adult patient.
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Event Description
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It was reported that during a code blue on a unit, the tubing set was obtained from the code cart, attached to 1 liter normal saline, primed and inserted into a pressure bag.When the nurse inflated the pressure bag, the tubing set separated and leaked from the blue safety clamp.Although the customer stated that there was a delay in treatment and the adult patient expired, the customer further stated that the patient's death was not a result of the defective tubing set.
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Search Alerts/Recalls
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