MAUDE Adverse Event Report: HAEMONETICS CORPORATION APH. BOWL, PLASMA LN 625B

Model Number	0625B-00
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no harm to the donor.Haemonetics has made multiple unsuccessful attempts to contact the customer for additional information.The bowl in question is not available for return, therefore evaluation cannot be performed.
Event or Problem Description
On (b)(6) 2020, haemonetics was notified of a device malfunction that occurred at the beginning of the procedure.The bowl was reported to have made a screeching noise followed by smoke from the centrifuge.

• Brand Name: APH. BOWL, PLASMA LN 625B
• Common Device Name: APH. BOWL, PLASMA LN 625B
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9974392
• Report Number: 1219343-2020-00031
• Device Sequence Number: 19469382
• Product Code: GKT
• UDI-Device Identifier: 10812747011686
• UDI-Public: (01)10812747011686(17)250131(10)2002003F
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK950033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 0625B-00
• Device Catalogue Number: 0625B-00
• Device Lot Number: 2002003F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1