MAUDE Adverse Event Report: HAEMONETICS CORPORATION MCS+ 8150 SYSTEM; MCS+ (RBC),LIST NO 08150-110-E

Model Number 08150-110-E

Device Problems Loose or Intermittent Connection (1371); Gas/Air Leak (2946)

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple unsuccessful attempts made to the center in regards to donor outcome and addition information.Haemonetics sent a field service engineer to evaluate the mcs+ system.Haemontics field service engineer inspected the high pressure compressor on the unit would not shut off on start up which signified that the pneumatics system had a leak.It was also noted the pneumatics manifold communication cable that plugs to the top deck board was not fully secured causing valves to open and close without lighting up.All connections to top deck board were secured and the high pressure compressor assembly was replaced.The line sensor was found to be out of specification and was replaced.All settings and parameters were verified and the unit was left meeting manufacturer's specifications and fit for use by the customer.

Event Description

On (b)(6) 2021, haemonetics was notified of an unconfirmed hemolysis event which occurred during a donation procedure utilizing the mcs+ collection system.The operator also reported valve v1 and v2 were not closing properly.There was no reported impact to the donor's health.

• Brand Name: MCS+ 8150 SYSTEM
• Type of Device: MCS+ (RBC),LIST NO 08150-110-E
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 12751397
• MDR Text Key: 280109943
• Report Number: 1219343-2021-00139
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/02/2021

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 Model Number: 08150-110-E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2003
• 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