Model Number 10016073 |
Device Problems
Fluid/Blood Leak (1250); Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Complaint file: not hispanic/latino, chemotherapy patient.
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Event Description
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The customer reported that the secondary tubing separated and leaked at the bottom of the drip chamber when opening the roller clamp to initiate a mannitol infusion.A primary maintenance fluid of normal saline was attached to the secondary set.The secondary set was newly out of the package when the event occurred.There was no patient or user harm reported.The event occurred in the cancer center.Received a copy of the customer's additional information request letter from fda which states, ¿secondary tubing set was used to prepare a bag of mannitol for administration to patient.The nurse inserted the spike into the bag of mannitol.When she went to open the roller clamp the tubing became detached from the bottom of the drip chamber and the medication went all over the nurse and the floor.The patient was not harmed in any way.The patient was later to receive dose of chemotherapy.If this had been attached to a bag of chemotherapy or other toxic agent there could have been significant risk to staff, patient, and visitors.This is the third occurrence this year with secondary tubing coming undone from the drip chamber in our department"."infuse mannitol as pre medication for chemotherapy".
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Manufacturer Narrative
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The customer¿s complaint of secondary set separated at drip chamber and leaked was confirmed.During visual inspection, it was noted that the pvc tubing was separated from the drip chamber outlet port.Fluid was leaking from the separation.Microscopic inspection observed no solvent applied to either side of the engagement during the manufacturing process.Dimensional analysis of the tubing was within iso-specification.The root cause of the customer¿s report was identified as a manufacturing issue due to no solvent being applied at the junction of the pvc tubing during the manufacturing process.
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Event Description
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It was reported that the secondary tubing separated and leaked at the bottom of the drip chamber when opening the roller clamp to initiate a mannitol infusion.A primary maintenance fluid of normal saline was attached to the secondary set.The secondary set was newly out of the package when the event occurred.There was no patient or user harm reported.The event occurred in the cancer center.Subsequently, a customer medwatch report was received from the fda which states: ¿secondary tubing set was used to prepare a bag of mannitol for administration to patient.The nurse inserted the spike into the bag of mannitol.When she went to open the roller clamp the tubing became detached from the bottom of the drip chamber and the medication went all over the nurse and the floor.The patient was not harmed in any way.The patient was later to receive dose of chemotherapy.If this had been attached to a bag of chemotherapy or other toxic agent there could have been significant risk to staff, patient, and visitors.This is the third occurrence this year with secondary tubing coming undone from the drip chamber in our department." intended procedure: "infuse mannitol as pre medication for chemotherapy".
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Search Alerts/Recalls
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