MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,06002-110-EXP-EW

Model Number	06002-110-EXP-EW
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Haemonetics sent a field service engineer to evaluate the pcs®2 plasma collection system.Haemonetics field service engineer performed calibration verification with no issues, unit met manufacturer specifications.There was no evidence of a device malfunction found.The disposables were discarded by customer, without physical sample haemonetics is unable to establish cause.
Event or Problem Description
On december 15 2020, haemonetics was notified of a donor fatality which had occurred within 24 hours of the donor's last attempted donation procedure, utilizing the pcs®2 plasma collection system.No plasma was collected during donation procedure as procedure was stopped due to a rbc less than error code.The donor was a previous donor with one reported reaction of an underdraw.On day of donation donor was provided an electrolyte drink and left the center in good health.Haemonetics was notified that the cause of death was a heart attack, cause of death was not confirmed through autopsy report as autopsy report was not available.

• 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 Key: 11174925
• Report Number: 1219343-2020-00145
• Device Sequence Number: 4086005
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: BK060033
• Number of Events Summarized: 1
• 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): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 06002-110-EXP-EW
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 56 YR
• Patient Weight: 98