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

Model Number	CSE-P-125
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer informed haemonetics that they would not be able to provide further patient information.
Event or Problem Description
On 21apr2021, haemonetics was notified of a long empty alert on cycle 5 of a vascular procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml system.During procedure 2 units of donated blood was needed to preclude permanent impairment where it would not have been needed if the issue with the device did not occur.Although it was not able to be confirmed with the operator that there was an inner core leak this error has in the past been an indicator of a potential issue with the bowl that has been reported.Awaiting lot number.There is no additional information available at this time.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Common Device Name: CSE-P-125, PRODUCT CODE: CAC
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11831914
• Report Number: 1219343-2021-00019
• Device Sequence Number: 4242535
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230320(10)0820012
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 0820012
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/17/2021
• 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: Required Intervention