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	Hemolysis (1886)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A haemonetics field service engineer evaluated the mcs®+ 8150 system.Haemonetics field service engineer was unable to duplicate the problem reported.The haemonetics field service engineer adjusted the line sensor and bowl optics values, device performed to specification with no errors.There was no evidence of a device malfunction found.The disposables used during reported event were not returned for manufacturer evaluation, without physical sample haemonetics is unable to establish cause.
Event or Problem Description
On (b)(6) 2021, haemonetics was notified of a hemolysis occurred alarm, utilizing the mcs®+ 8150 system.Operator confirmed hemolysis occurred.Multiple unsuccessful attempts were made to obtain additional information, the patients health status and impact is unknown.

• 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: 11389453
• Report Number: 1219343-2021-00010
• Device Sequence Number: 4037032
• Product Code: GKT
• UDI-Device Identifier: 30812747013875
• UDI-Public: (01)30812747013875
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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: 01/29/2021
• Initial Report FDA Received Date: 02/27/2021
• 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: Other