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

Model Number 0625B-00

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Blood Loss (2597)

Event Date 01/31/2020

Event Type  malfunction  

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 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
• Type of Device: BMB PLS BOWL
• 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: 9771925
• MDR Text Key: 181455356
• Report Number: 1219343-2020-00009
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747011686
• UDI-Public: (01)10812747011686(17)241031(10)1911035F
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 0625B-00
• Device Lot Number: 1911035F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2019
• 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
• Patient Age: 51 YR
• Patient Weight: 82