MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS®2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,06002-110-EXP-EW

Model Number	PCS2,LIST NO,06002-110-EXP-EW
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/07/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
On (b)(6) 2020, the customer was informed, by the clemson police department, that the donor had died while using methamphetamine.A field service engineer was dispatched and inspected the pcs2 machine and no issues were found.Diagnostic checks were normal and unit meets manufacturer specifications.
Event or Problem Description
On (b)(6) 2020, haemonetics was informed by the customer of a donor fatality following a successful plasmapheresis procedure on a pcs2 plasma collection system.The donor left in good health following the completion of the donation procedure.No medical interventions were necessary.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2,LIST NO,06002-110-EXP-EW
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9806561
• Report Number: 1219343-2020-00017
• Device Sequence Number: 13599755
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK060033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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: PCS2,LIST NO,06002-110-EXP-EW
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/09/2020
• 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
• Patient Age: 54 YR
• Patient Weight: 92