MAUDE Adverse Event Report: HAEMONETICS, INC. MCS+9000 WITH PLT & PLASMA SET W/FILTERS

Model Number 999FF-P-SL

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

The product sample has not been returned to manufacturing, therefore an evaluation could not be performed.The status of the disposables is unknown, however there were no recalls or adverse trends related to the product lots used in the procedure.

Event Description

On (b)(6) 2021, haemonetics was notified of a non-compliance in residual white blood cells during sampling plan after plasma collection utilizing the mcs+9000 mobile collection system and platelet and plasma set (case patient (b)(6) and case patient (b)(6)); no alarm displayed.There was no report of donor harm.

• Brand Name: MCS+9000 WITH PLT & PLASMA SET W/FILTERS
• Type of Device: MCS+9000 WITH PLT & PLASMA SET W/FILTERS
• Manufacturer (Section D): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 13334988
• MDR Text Key: 291295367
• Report Number: 1219343-2022-00001
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK010035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: 999FF-P-SL
• Device Lot Number: 8321073
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1