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

Model Number 0625B-00

Device Problems Smoking (1585); Noise, Audible (3273)

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

Event Date 03/19/2020

Event Type  malfunction  

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 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
• Type of Device: APH. BOWL, PLASMA LN 625B
• 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: 9974392
• MDR Text Key: 188096479
• Report Number: 1219343-2020-00031
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747011686
• UDI-Public: (01)10812747011686(17)250131(10)2002003F
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK950033
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0625B-00
• Device Catalogue Number: 0625B-00
• Device Lot Number: 2002003F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1