MAUDE Adverse Event Report: HAEMONETICS, INC. CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML

Model Number CSE-P-125

Device Problem Material Integrity Problem (2978)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

On april 27, 2022, haemonetics was notified of a long empty error message with over estimation of rbc volume (but no waste contamination).The error message was seen on emptying of the 10th bowl and final bowl on this device utilizing the cell saver® elite processing set - 125ml in the united kingdom.There were no obvious internal cracks to the bowl reported at this time.

Manufacturer Narrative

On june 2, 2022, it was reported the investigation found that an inner core leak was observed on a video that was provided and cracks at the core area of the bowl were confirmed.Although there was no serious injury or harm, past reporting (1219343-2020-00001-01) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of 1219343-2020-00001-01 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 - 125ML
• Manufacturer (Section D): HAEMONETICS, INC.; 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: 14633348
• MDR Text Key: 300468374
• Report Number: 1219343-2022-00032
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2022

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
• Device Operator: Health Professional
• Device Model Number: CSE-P-125
• Device Lot Number: 121024
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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