MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP

Model Number 70105.1712

Device Problems Pumping Stopped (1503); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that the rotaflow device shut off while on a patient.No further information was provided.(b)(4).Reference mfr report 8010762-2014-00179.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP
• Type of Device: ROTAFLOW
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 3787533
• MDR Text Key: 4361986
• Report Number: 3008355164-2014-00080
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2014,03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70105.1712
• Device Catalogue Number: 70105.1712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other