MAUDE Adverse Event Report: HAEMONETICS CORPORATION LN CSE-E-US MACHINE; CELL SAVER ELITE

Model Number CSE-E-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 11/19/2019

Event Type  Death  

Manufacturer Narrative

Preliminary autopsy found microthrombi consistent with endometrial material in all lobes of both lungs.A field service engineer inspected and performed all functional test and confirmed that all functions passed.The unit is operating within manufacturing standards.

Event Description

On january 2, 2020, haemonetics was informed of a patient fatality via a medwatch 3500a (003902226-2019-0001) sent in the mail.Surgery progressed normally.Est.Blood loss 300ml.At conclusion when closing skin and returning blood to patient the patient went into cardiac arrest.Patient expired despite resuscitation efforts.

• Brand Name: LN CSE-E-US MACHINE
• 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: 9643651
• MDR Text Key: 176858750
• Report Number: 1219343-2020-00004
• 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: other,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSE-E-US
• Device Lot Number: 15H569SPG
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• 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: 26 YR