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

Model Number	0625B-00
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were no adverse reaction or injury experienced by the donor.The bowl and blood that was collected was disposed of due to malfunction.No physical sample is available for evaluation.Without the implicated sample, the exact cause of this incident could not be determined.Device history record (dhr) was reviewed and lot was manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations that would have contributed to the reported incident.
Event or Problem Description
On (b)(6) 2020 - haemonetics was informed by the customer of a device malfunction that occurred during a platelet apheresis procedure that resulted in hearing a screeching noise and a small amount of smoke was observed.

• Brand Name: APH. BOWL, PLASMA LN 625B
• Common Device Name: BMB PLS BOWL
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9771925
• Report Number: 1219343-2020-00009
• Device Sequence Number: 14106032
• Product Code: GKT
• UDI-Device Identifier: 10812747011686
• UDI-Public: (01)10812747011686(17)241031(10)1911035F
• 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): 01/31/2020

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 Model Number: 0625B-00
• Device Lot Number: 1911035F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 82