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

Model Number	08150-110-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were multiple unsuccessful attempts made to center in regards to donor outcome and additional information.Haemonetics sent a field service engineer to evaluate the mcs+ system.Haemonetics field service engineer inspected the unit and could not duplicate the fault.All air detectors working per manufacturer's specifications.All other parameters verified, system met manufacturer's specifications and is ready to use.Unaware if disposables are available for return, evaluation pending return of physical sample.
Event or Problem Description
On august 17, 2021, haemonetics was notified that operator observed a bubble entering donors arms at the vein puncture during saline return, utilizing the mcs+ system.The mcs+ system did not alarm for air detected.

• Brand Name: MCS+ 8150 SYSTEM
• Common Device Name: MCS+ (RBC),LIST NO 08150-110-E
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 12483000
• Report Number: 1219343-2021-00123
• Device Sequence Number: 11984849
• Product Code: GKT
• UDI-Device Identifier: 30812747013875
• UDI-Public: (01)30812747013875
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: BK060065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: 08150-110-E
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention