MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE

Model Number	LN CSE-E-US MACHINE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/21/2017
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: CELL SAVER ELITE
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 9638155
• Report Number: 1219343-2020-00003
• Device Sequence Number: 2923551
• Product Code: CAC
• UDI-Device Identifier: 30812747016616
• UDI-Public: (01)30812747016616
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K120586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: LN CSE-E-US MACHINE
• Device Catalogue Number: CSE-E-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 27 YR