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

Model Number CSE-P-125-JA

Device Problem Material Integrity Problem (2978)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, haemonetics was notified that a return error message appeared at returning and return bag amount became more than 200ml during a procedure in (b)(6) utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.There was no reported impact to the health of the patient.

Manufacturer Narrative

On (b)(6) 2021 haemonetics manufacturing performed a visual inspection of the received bowl from the cell saver® elite set 125ml and confirmed blood in the inner core with a crack in the inner core base.Although there was no serious injury or harm, 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 the event of the that report.

• Brand Name: CELL SAVER® ELITE® 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, INC.; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 13042897
• MDR Text Key: 290149811
• Report Number: 1219343-2021-00157
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-P-125-JA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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