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

Model Number 06002-CP-110

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2020

Event Type  malfunction  

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 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
• Type of Device: PCS2,LIST NO. 06002-CP-110
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, ma
• MDR Report Key: 9860898
• MDR Text Key: 184303511
• Report Number: 1219343-2020-00024
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747011686
• UDI-Public: (01)10812747011686(17)241130(10)1912035F
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 06002-CP-110
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 81