MAUDE Adverse Event Report: HAEMONETICS CORPORATION CS ELITE PROCESSING KIT, 70ML

Model Number	CS ELITE PROCESSING KIT, 70ML
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The blood volume lost was 140ml with no consequence to the patient and allogenic red cells pellet were transfused back.Instigation of the unit is still on-going.
Event or Problem Description
On (b)(6) 2020, a customer informed haemonetics of adverse event that occurred during a surgery for congenital cardiopathy.The customer reported that there was an audible noise during the procedure and procedure was stopped immediately.In addition, plastic dust was found on the bowl.

• Brand Name: CS ELITE PROCESSING KIT, 70ML
• Common Device Name: CS ELITE PROCESSING KIT, 70ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9787998
• Report Number: 1219343-2020-00010
• Device Sequence Number: 2650305
• Product Code: CAC
• UDI-Device Identifier: 10812747016520
• UDI-Public: (01)10812747016520(17)220916(10)0919014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101907
• 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): 02/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: CS ELITE PROCESSING KIT, 70ML
• Device Lot Number: 0919014
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR