MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM; CSE-P-125

Model Number CSE-P-125

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

A haemonetics field service engineer evaluated the cell saver® elite® autotransfusion system and downloaded the procedure events data.The system was deemed to fit to use with no device malfunctions found.The cell saver® elite set - 125ml was received for manufacturing evaluation, blood was identified in the inner core and cracks were also identified in the inner core.

Event Description

On february 08 2021, haemonetics was notified of a long empty alert on cycle 1 of a vascular procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml system.During procedure fluid was also detected in the centrifuge well and in the waste bag.A new set was used to continue procedure, fluid detected in centrifuge was again present.Due to incident transfusion was necessary, patients health status was reported as fine.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Type of Device: CSE-P-125
• 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: 11443258
• MDR Text Key: 238601324
• Report Number: 1219343-2021-00012
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230320(10)0320055
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120586
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 0320055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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
• Patient Outcome(s): Other