MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE

Model Number LN CSE-E-US MACHINE

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 08/21/2017

Event Type  Death  

Manufacturer Narrative

The intraoperative process went smoothly except for a higher than expected blood loss (1000mls).All machine processing and washing etc went well with no mechanical issues.No messages were displayed on device.Adequate anticoagulation and wash volume were utilized.The device was taken out of service.

Event Description

On 12-december-2019 haemonetics was informed of a patient fatality which occurred on (b)(6) 2017 using a cell saver elite machine.The patient fatality occured post-operation procedure for removal of fibroids.Near the end of the procedure anesthesia stated that the patient was having some hemodynamic instability and the instability occurred shortly after the infusion of cell saver washed product.Patient received approx.300 ml of 400 ml available for reinfusion of washed cells.The patient expired later that night/early morning.

• Brand Name: CELL SAVER ELITE
• Type of Device: CELL SAVER ELITE
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, MA 02110
• MDR Report Key: 9638155
• MDR Text Key: 176628270
• Report Number: 1219343-2020-00003
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 30812747016616
• UDI-Public: (01)30812747016616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LN CSE-E-US MACHINE
• Device Catalogue Number: CSE-E-US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2012
• 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): Death
• Patient Age: 27 YR