MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML, PRODUCT CODE CAC

Model Number	CSE-P-125-JA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the returned product and photos confirmed the malfunction of inner crack of the bowl.Although there was no serious injury or harm, past reporting indicates this particular malfunction has been associated with a reported death.The investigation of the past report that had a death indicated the inner core leak malfunctioned 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 leak due the confirmed malfunction that occurred.Manufacturing evaluation confirmed inner core crack malfunction.
Event or Problem Description
Customer in (b)(6) informed haemonetics the cell saver elite device displayed a long empty error while using a similar device disposable set cell saver elite set - 125ml.There was no report of patient ha.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Common Device Name: CELL SAVER ELITE SET - 125ML, PRODUCT CODE CAC
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11849596
• Report Number: 1219343-2021-00021
• Device Sequence Number: 3148778
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)0820066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162423
• 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): 04/20/2021

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: 08/20/2023
• Device Model Number: CSE-P-125-JA
• Device Lot Number: 0820066
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1