MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYS

Lot Number 93201146

Device Problem No Display/Image (1183)

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

Event Date 02/20/2013

Event Type  Injury  

Event Description

During a sales call, the customer informed me of a pt transport via ambulance about a month ago where they experienced numerous error messages and pump stoppages form the rotaflow.The transfer was by ambulance from (b)(6) to (b)(6) state (b)(6) 2013.During the transport the numeric display on the console changed from numbers to xxx twice and from numbers to dashes twice.The centrifugal pump stopped once.The pt has been weaned from cps.(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365186
• MDR Text Key: 5114043
• Report Number: 3008355164-2014-00339
• 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: 12/15/2014,03/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 93201146
• Other Device ID Number: 9345393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention