MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CS ELITE PROCESSING KIT, 125ML

Model Number CSE-P-125

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

There was no sample or photo provided to haemonetics.It is not possible for haemonetics to determine the root cause for the reported incident through investigation without a sample provided for evaluation.

Event Description

On (b)(6) 2020, haemonetics was notified of a failed centrifuge, which occurred during a procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system, and cell saver® elite set - 125ml.Customer was able to complete procedure utilizing a different disposable set.There was no reported impact to patients' health.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Type of Device: CS ELITE PROCESSING KIT, 125ML
• 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: 10739531
• MDR Text Key: 213181796
• Report Number: 1219343-2020-00099
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230320(10)0320055
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 0320055
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2020
• 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