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

Model Number	CSE-P-125
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient was reported to have no consequence or injury for this event; however, there was a potential of 600 mls.Of blood left in the reservoir.The investigation of the bowl could contribute to the error of long empty between cycles 2 and 3 and procedure timings.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 or Problem Description
On (b)(6) 2020, haemonetics was notified of a long empty alarm which had occurred on cycle 3 during a spinal procedure, utilizing the cell saver® elite® auto transfusion system.The device stopped as a result of the error.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
• Common Device Name: CS ELITE PROCESSING KIT, 125ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9922638
• Report Number: 1219343-2020-00027
• Device Sequence Number: 3320248
• Product Code: CAC
• UDI-Device Identifier: 10812747016544
• UDI-Public: (01)10812747016544(17)220818(10)0819033
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: CSE-P-125
• Device Lot Number: 0819033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1