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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORP PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,,

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HAEMONETICS CORP PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,, Back to Search Results
Model Number 06002-CP-110
Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2016
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
Haemonetics received a complaint on (b)(6) 2016 for a report of anticoagulant (ac) depletion with no donor reaction.
 
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Brand Name
PCS®2 PLASMA COLLECTION SYSTEM
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,,
Manufacturer (Section D)
HAEMONETICS CORP
400 wood rd
braintree MA 02184
Manufacturer (Section G)
HAEMONETICS CORP
400 wood rd
braintree MA 02184
Manufacturer Contact
julie smith, rn
400 wood rd
braintree, MA 02184
7819170643
MDR Report Key6105723
MDR Text Key60445481
Report Number1219343-2016-00081
Device Sequence Number0
Product Code GKT
Reporter Country CodeUS
PMA/PMN Number
BK920039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Phlebotomist
Device Model Number06002-CP-110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/19/2016
Initial Date FDA Received11/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/1997
Is the Device Single Use? No
Type of Device Usage Reuse
Removal/Correction NumberB-0349-2016
Patient Sequence Number1
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