MAUDE Adverse Event Report: HAEMONETICS CORPORATION MCS®+ MOBILE COLLECTION SYSTEM; LIST NO: 09000-220-ED,MCS+

Model Number 09000-220-ED

Device Problem Insufficient Information (3190)

Patient Problem Vaso-Vagal Response (2661)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

Limited donor/patient information was provided at this time.Follow up with donor indicated there were no lasting signs or symptoms resulted from reaction.The customers onsite technician was scheduled to evaluate the device.

Event Description

On (b)(6) 2018 haemonetics was notified of an adverse reaction which had occurred during the plasma donation procedure, utilizing the mcs®+ mobile collection system.The plasma collection procedure was discontinued, donor experienced vomiting and a vasovagal faint episode.There were no error messages or alarms experienced during the procedure.The amount of plasma collected by the mcs®+ mobile collection system was unknown, however 500ml of saline was administered.Following the administration of saline compensation, the donor made a full recovery.

• Brand Name: MCS®+ MOBILE COLLECTION SYSTEM
• Type of Device: LIST NO: 09000-220-ED,MCS+
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 9896331
• MDR Text Key: 185672265
• Report Number: 1219343-2018-00054
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK050047
• 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: 10/29/2018

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
• Device Operator: Health Professional
• Device Model Number: 09000-220-ED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/1999
• 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