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

Model Number CSE-P-125-JA

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information was provided at this time.The bowl from the cell saver elite set was returned and evaluated by haemonetics.It was noted during investigation that blood was seen on the inner core.Bowl decompression testing confirmed the blood outflow from the inner core and the outer core welding and several cracks confirmed in the inner core of bowl.

Event Description

On (b)(6) 2020 haemonetics was notified of a long empty error message which was displayed on the 5th cycle of the return process during a cardiac procedure in (b)(6), utilizing the cell saver elite autotransfusion system and cell saver elite set - 125ml.A total blood volume of 6000ml was processed and there was no reported impact to patients' health.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE SET - 125ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 10116295
• MDR Text Key: 200844135
• Report Number: 1219343-2020-00042
• 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: 05/13/2020

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 Expiration Date: 01/01/2023
• Device Model Number: CSE-P-125-JA
• Device Lot Number: 0120047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2020
• 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