MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MCP00967621#RFD 20-973 ROTAFLOW DRIVE; ROTAFLOW CONSOLE

Catalog Number 70102.2161

Device Problem Pumping Stopped (1503)

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

Event Date 11/25/2014

Event Type  Injury  

Event Description

It was reported that rota flow drive displayed a "head error" at time of use.Customer was required to hand crank while a backup device was brought in.No reported patient effect.(b)(4).Mfr ref#8010762-2014-01358.

• Brand Name: MCP00967621#RFD 20-973 ROTAFLOW DRIVE
• Type of Device: ROTAFLOW CONSOLE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4366314
• MDR Text Key: 5261422
• Report Number: 3008355164-2014-00306
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2014,11/26/2014

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: Health Professional
• Device Catalogue Number: 70102.2161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 108