MAUDE Adverse Event Report: HAEMONETICS CORPORATION MCS®+ MOBILE COLLECTION SYSTEM; MCS+,220V ENGL,LN 09000-220-E

Model Number 09000-220-E

Device Problem Connection Problem (2900)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vaso-Vagal Response (2661)

Event Date 06/30/2018

Event Type  Injury  

Manufacturer Narrative

Donor/patient information was not provided at this time.A haemonetics field service engineer evaluated the device, determined the safety pcb board was defective and caused the error message encountered.The safety pcb was replaced and device returned to service.

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 due to an error message "watchdog: id timeout".The donor then experienced a grade 3 vasovagal faint episode.The mcs®+ mobile collection system collected 911ml of plasma and 500ml of saline administered.Following the administration of saline compensation, the donor made a full recovery and left the center in good health.

• Brand Name: MCS®+ MOBILE COLLECTION SYSTEM
• Type of Device: MCS+,220V ENGL,LN 09000-220-E
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer st; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 9896326
• MDR Text Key: 185672910
• Report Number: 1219343-2018-00024
• 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: 07/04/2018

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-E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2006
• 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