MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 225ML

Model Number CSE-P-225-JA

Device Problem Material Integrity Problem (2978)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, haemonetics was notified of a inner core leak post procedure in japan, utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 225ml.There was no reported impact to patient health.

Manufacturer Narrative

On (b)(6) 2022 the complaint investigation of the returned bowl from the cell saver® elite set - 225ml confirmed a crack in the inner core base.Although there was no injury or harm to the patient, past reporting (b)(4) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of (b)(4) indicated the inner core of the bowl malfunctioned, via a crack, but did not cause or contribute to the reported incident according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing due to the event of the past report.

• Brand Name: CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE SET - 225ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 16023548
• MDR Text Key: 308120302
• Report Number: 1219343-2022-00060
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-P-225-JA
• Device Lot Number: 0422077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• 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