HAEMONETICS CORP PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,,
|
Back to Search Results |
|
Model Number 06002-110-NA |
Device Problems
Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/06/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Haemonetics has requested that the rotors be returned for evaluation, however, the customer has not 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.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.Not returned.
|
|
Event Description
|
Haemonetics received a complaint on (b)(6) 2016 for a report of anticoagulant (ac) depletion noticed at end of procedure, no donor reaction.Center technician found the rotors were not seated properly.
|
|
Search Alerts/Recalls
|
|
|