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 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

There was no consequence or injury to the patient for this event.Although there was a long empty alarm on cycle 11 and the cycles continued until the end of the operation, the customer did not follow the guidance to stop the cell salvage upon receiving a long empty alarm.The device was sent to the customers bioengineering department.The customer did not inspect the bowl for cracks and discarded the bowl, which 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 informed by the customer of a device malfunction receiving a long empty started at cycle 11 and continuing (each cycle) until the operation finished at cycle 20.

• 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: 9978739
• MDR Text Key: 222559125
• Report Number: 1219343-2020-00038
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)220517(10)0519023
• 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: 01/28/2020

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: 05/06/2024
• Device Model Number: CSE-P-125
• Device Lot Number: 0519023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2019
• 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