MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE, CM, PRODUCT CODE: CAC

Model Number CSE-E-CM

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being sent as part of a service record retrospective review that was self identified by haemonetics.Field service technician reported dried blood in smart suction tubing, filter, and compressor.When smartsuction is ran and compressor heats up it starts to smell.All components need to be replaced.Can not complete.The suspect device/part was not returned to haemonetics, without physical sample provided for evaluation, the root cause cannot be determined.

Event Description

Haemonetics was notified that a customer detected a burning smell.There was no donor involvement.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE, CM, PRODUCT CODE: CAC
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 11812254
• MDR Text Key: 250224658
• Report Number: 1219343-2021-00069
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 308127470166
• UDI-Public: (01)308127470166(22)12D134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-E-CM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1