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

Model Number	06002-CP-110
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Donor was monitored and was stable upon release.A field service engineer was dispatched and inspected the pcs2 machine.The engineer realigned centrifuge lid and tightened loose hardware.The blood pump motor was also replaced.Calibrations checked and adjusted as required.Unit meets manufacturer specifications.Photo analysis of the bowl shows a bowl full of dark colored red blood cells.No evidence of damaged red blood cells are visible.No defects that could possibly create hemolysis were identified (no folds, molding defects, sharp or rough edges, foreign objects).
Event or Problem Description
On february 21, 2020, haemonetics was informed by the customer of an adverse event and device malfunction during a plasmapheresis procedure.There was a possibility of the donor receiving hemolized red blood cells.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2,LIST NO. 06002-CP-110
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9860898
• Report Number: 1219343-2020-00024
• Device Sequence Number: 2611612
• Product Code: GKT
• UDI-Device Identifier: 10812747011686
• UDI-Public: (01)10812747011686(17)241130(10)1912035F
• 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): 02/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 06002-CP-110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2020
• 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: Other
• Patient Age: 22 YR
• Patient Weight: 81