ICU MEDICAL, INC. TRANSPAC; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR, CATHETER, CONTINUOUS FLUSH
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Model Number 42587-05 |
Device Problems
Device Inoperable (1663); Defective Device (2588); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/12/2018 |
Event Type
malfunction
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Event Description
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The ir team was planning to use this monitoring device that measures blood pressure within the fistula during a procedure.However, the team attempted to assemble the product they realized one of the pieces was bonded together.The team obtained another kit, however, upon opening it, they found that the product was again bonded.The team then pulled all of the product in stock (7 products) and found that 6 of those products had the same lot number as the product that we discarded and 1 had a different lot number.The team opened the product that had its own lot number and that product was fine and worked as it should have.Upon later inspection of the other remaining 6 with the same "bad" lot numbers were bonded.This product has since been taken out of circulation.The lot number for the defective kits is 3598346.The kit the team ended up using in this procedure that was not bonded is from lot 3338172.
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