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

Model Number CSE-P-125

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Patient was reported to have no consequence or injury for this event and 875 mls.Of blood was reinfused back to the patient.The investigation of the bowl could contribute to the error of long empty alarm.The customer discarded the bowl therefore could not be evaluated by haemonetics.However, per investigation the most likely cause of the error is the bowl and is associated with safety notice crl-100260-ie (mhra fscafy20- 01).

Event Description

On (b)(6) 2020, haemonetics was notified of a long empty alarm which had occurred on cycle7 utilizing the cell saver® elite® auto transfusion system.The device stopped as a result of the error.

• 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
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, ma
• MDR Report Key: 9923288
• MDR Text Key: 208350586
• Report Number: 1219343-2020-00033
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)220318(10)0519049
• 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,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/09/2020

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: 05/19/2022
• Device Model Number: CSE-P-125
• Device Lot Number: 0519049
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1