MAUDE Adverse Event Report: HAEMONETICS CORPORATION ACP215 AUTOMATED CELL PROCESSING SYSTEM; ACP215,220V,LN 02215-220-E

Model Number 02215-220-E

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

The driver card pcb card was replaced and the machine was working properly.On (b)(6) 2021, driver pcb sample was returned to haemonetics for manufacturing evaluation.Based on visual inspection the u5 component of the driver pcb was burnt.Manufacturing evaluation determined that the driver pcb failure was caused by u5 component failure, the cause could not be determined.

Event Description

On (b)(6) 2020 haemonetics was notified of a burnt smell upon start-up on a acp 215 automated cell processing system in singapore.This incident occurred during start-up, there was no donor involved in the incident.

• Brand Name: ACP215 AUTOMATED CELL PROCESSING SYSTEM
• Type of Device: ACP215,220V,LN 02215-220-E
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 11222062
• MDR Text Key: 229078137
• Report Number: 1219343-2020-00163
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 30812747015817
• UDI-Public: (01)30812747015817
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: BK040077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/12/2021

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: 02215-220-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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