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

Model Number CSE-P-125

Device Problem Fluid/Blood Leak (1250)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

Customer informed haemonetics that they would not be able to provide further patient information.

Event 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
• Type of Device: CSE-P-125, PRODUCT CODE: CAC
• 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: 11831914
• MDR Text Key: 250865478
• Report Number: 1219343-2021-00019
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230320(10)0820012
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 0820012
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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): Required Intervention