MAUDE Adverse Event Report: HAEMONETICS CORPORATION MCS+ 9000 MOBILE PLATELET COLLECTION SYSTEM; 09000-220-ED,MCS+

Model Number 09000-220-ED

Device Problem Smoking (1585)

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

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer replaced the drive pcb and the mcs®+ 9000 mobile platelet collection system was found to meet specifications.

Event Description

On june 12 2020 haemonetics was notified of burning smell and smoke coming from the drive pcb of the mcsâ®+ 9000 mobile platelet collection system during installation in (b)(6).There was no patient/ donor involved.

• Brand Name: MCS+ 9000 MOBILE PLATELET COLLECTION SYSTEM
• Type of Device: 09000-220-ED,MCS+
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 10255300
• MDR Text Key: 198281513
• Report Number: 1219343-2020-00065
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: BK050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/12/2020

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: 09000-220-ED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2017
• 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