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

Model Number ATLG

Device Problems Air Leak (1008); Crack (1135); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 01/12/2017

Event Type  malfunction  

Event Description

Upon running cell saver, blood noted to have leaked out of reservoir and into the actual machine.No blood was given to the patient.The leakage most likely from a crack in the reservoir created upon installing wash kit.Indicated error message of "not installed correctly." all of a sudden the machine started running.Staff found large disposal collection bag on the side of the machine was full of fluid and air to the point of bursting and turned the machine off.

• Brand Name: AUTOLOG
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS, INC.; 7611 northland dr.; minneapolis MN 55428
• MDR Report Key: 6285510
• MDR Text Key: 66063507
• Report Number: 6285510
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ATLG
• Device Catalogue Number: ATLG
• Device Lot Number: ATLG012459
• Other Device ID Number: CLINICAL ENGINEER L094369
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR