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

Model Number CS ELITE PROCESSING KIT, 70ML

Device Problem Insufficient Information (3190)

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

Event Date 01/31/2020

Event Type  Injury  

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 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
• Type of Device: CS ELITE PROCESSING KIT, 70ML
• 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: 9787998
• MDR Text Key: 182411399
• Report Number: 1219343-2020-00010
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016520
• UDI-Public: (01)10812747016520(17)220916(10)0919014
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101907
• 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: 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
• Device Operator: Health Professional
• Device Model Number: CS ELITE PROCESSING KIT, 70ML
• Device Lot Number: 0919014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR