HAEMONETICS CORP PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,,
|
Back to Search Results |
|
Model Number 06002-CP-110 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/14/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Haemonetics has requested that the rotors be returned for evaluation, however, the customer has not responded 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.
|
|
Event Description
|
Haemonetics received a complaint on 10/14/2016 for a report of anticoagulnat (ac) depletion noticed at end of procedure, no donor reaction.
|
|
Search Alerts/Recalls
|
|
|