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

Model Number 08150-110-E

Device Problem Insufficient Information (3190)

Patient Problem Air Embolism (1697)

Event Date 08/17/2021

Event Type  Injury  

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 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
• 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: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 12483000
• MDR Text Key: 271932618
• Report Number: 1219343-2021-00123
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747013875
• UDI-Public: (01)30812747013875
• 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: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 08150-110-E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2013
• 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): Required Intervention