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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,06002-110-EXP-EW
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HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,06002-110-EXP-EW Back to Search Results
Model Number 06002-110-EXP-EW
Medical Device Problem Code Increase in Pressure (1491)
Health Effect - Clinical Code Hemolysis (1886)
Date of Event 11/11/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Haemonetics field service engineer evaluated the pcs2 plasma collection system, the cuff pressure was found to be high.The cuff was calibrated and pressure issue was resolved.The sample was not returned to haemonetics for evaluation, root cause could not be determined.
 
Event or Problem Description
On (b)(6) 2020, haemonetics was notified of a suspected hemolysis event utilizing the pcs2 plasma collection system.Patient status is unknown as haemonetics was unable to obtain additional information from customer.
 
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Brand Name
PCS2 PLASMA COLLECTION SYSTEM
Common Device Name
PCS2,LIST NO,06002-110-EXP-EW
Manufacturer (Section D)
HAEMONETICS CORPORATION
125 summer street
boston MA 02110
MDR Report Key10991230
Report Number1219343-2020-00132
Device Sequence Number690794
Product Code GKT
UDI-Device Identifier30812747011970
UDI-Public(01)30812747011970
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
BK060033
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number06002-110-EXP-EW
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/11/2020
Initial Report FDA Received Date12/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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