MAUDE Adverse Event Report: HAEMONETICS CORPORATION EHAEMONETICS CELL SAVER ELITE SYSTEMLITE; APPARATUS, AUTOTRANSFUSION

Catalog Number CSE-P-225

Device Problem Defective Device (2588)

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

Event Date 01/07/2020

Event Type  malfunction  

Event Description

Perfusionist reports that the first processed bowl was "watery" when using the cell saver and the machine did not give an error message.

• Brand Name: EHAEMONETICS CELL SAVER ELITE SYSTEMLITE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer st; boston MA 02110
• MDR Report Key: 9798352
• MDR Text Key: 182355430
• Report Number: 9798352
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2020,01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CSE-P-225
• Device Lot Number: 0919052
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA