MAUDE Adverse Event Report: MEDTRONIC, INC. AUTOLOG; APPARATUS, AUTOTRANSFUSION

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

Cell saver staff called in to spin down blood collected via cell saver during surgery.Per cell saver staff, as they were spinning down collected blood and fluid, the medtronic autolog autotransfusion system began spinning very fast - much faster than expected.

• Brand Name: AUTOLOG
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 12091844
• MDR Text Key: 259141586
• Report Number: 12091844
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2021
• Date Report to Manufacturer: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA