PCS?2 PLASMA COLLECTION SYSTEM 06002-110-EXP-EW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for PCS?2 PLASMA COLLECTION SYSTEM 06002-110-EXP-EW manufactured by Haemonetics Corporation.

Event Text Entries

[185472559] There was no adverse reaction or injury experienced during the donation procedure, the donor was reported to have left the center in stable condition. A haemonetics field service engineer evaluated the suspected device and found that the unit meets all specifications, there were no faults observed.
Patient Sequence No: 1, Text Type: N, H10


[185472560] On (b)(6) 2018 haemonetics was notified of a donor fatality which had occurred within 24 hours of the donor's last plasma donation procedure, utilizing the pcs? 2 plasma collection system. The plasma collection procedure was not completed due to an error message "air in ac line" and anticoagulant depletion observed. The pcs? 2 plasma collection system collected 846ml of plasma, however there was a loss of 200ml of red blood cells. The cause of death was reported to be an undisclosed underlying heart condition; a copy of the coroner's report was available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219343-2018-00042
MDR Report Key9896330
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2018-09-24
Date of Event2018-09-22
Date Mfgr Received2018-09-24
Device Manufacturer Date2015-10-01
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JANICE KISER
Manufacturer Street125 SUMMER STREET
Manufacturer CityBOSTON, MA
Manufacturer CountryUS
Manufacturer G1HAEMONETICS CORPORATION
Manufacturer Street125 SUMMER STREET
Manufacturer CityBOSTON, MA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePCS?2 PLASMA COLLECTION SYSTEM
Generic NamePCS2,LIST NO,06002-110-EXP-EW
Product CodeGKT
Date Received2020-03-30
Model Number06002-110-EXP-EW
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHAEMONETICS CORPORATION
Manufacturer Address125 SUMMER STREET BOSTON, MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-30

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