MAUDE Adverse Event Report: HAEMONETICS CORPORATION MCS®+ 8150 MULTICOMPONENT COLLECTION SYSTEM; MCS+ 8150

Model Number MCS+ (RBC),LIST NO 08150-110-E

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in the incident.A field service engineer was dispatched to inspect the mcs+ 8150 machine, however the malfunction could not be determined on site.The machine will be returned to the manufacturing facility for further investigation.

Event Description

On (b)(6) 2020, haemonetics was informed by the customer of a device malfunction resulting in a burning smell.

• Brand Name: MCS®+ 8150 MULTICOMPONENT COLLECTION SYSTEM
• Type of Device: MCS+ 8150
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, ma
• MDR Report Key: 9847505
• MDR Text Key: 183889504
• Report Number: 1219343-2020-00021
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060023
• 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: 02/17/2020

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: MCS+ (RBC),LIST NO 08150-110-E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2016
• 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