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

Model Number	CSE-P-125
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 and a visible crack was identified on the inner core of the bowl.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 the event of the past report.
Event or Problem Description
On (b)(6) 2021, haemonetics was notified of a long empty error message following emptying 7th or 8th bowl in the (b)(6), utilizing the cell saver® elite processing set - 125ml.Volume of blood lost due to the long empty was approximately.125 ml (i.E.The volume of the bowl that wouldn't empty).There were no obvious internal cracks seen at the time.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Common Device Name: CELL SAVER ELITE SET - 125ML,
• Manufacturer (Section D): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• MDR Report Key: 12699502
• Report Number: 1219343-2021-00135
• Device Sequence Number: 4703510
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240111(10)0121024
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: CSE-P-125
• Device Lot Number: 0121024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1