HAEMONETICS CORP PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,,
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Model Number 06002-CP-110 |
Device Problems
Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Haemonetics has requested that the rotors be returned for evaluation, however, none have been returned to date.This issue of anticoagulant (ac) depletion has been investigated under a corrective action.The results of that investigation determined the likely cause was the harsh cleaning solution used to clean the pump rollers at the customer site can cause damage to the pump rollers which may lead to a device malfunction.New rotors were sent to the customer for the on-site technician to replace.Not returned.
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Event Description
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Haemonetics received a complaint on (b)(6) 2016 for a report of anticoagulant (ac) depletion noticed at end of procedure, no donor reaction.
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Search Alerts/Recalls
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