Model Number 06002-CP-110 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The customer does not have the rotors available for evaluation.There was no adverse donor reaction due to the ac depletion.This issue of anticoagulant 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.These chemicals 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.Haemonetics confirmed that the customer is aware of the haemonetics medical device safety alert regarding the proper cleaning solutions to use to prevent the early degradation of the rotors.
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Event Description
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On (b)(6) 2017 the device operator reported to haemonetics that an ac depletion was observed during a routine plasma collection procedure on the pcs®2 plasma collection system.The operator reported that there was no adverse reaction experienced by the donor, no medical intervention was required.
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Search Alerts/Recalls
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