MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS

Model Number MCP00952291

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 10/18/2011

Event Type  malfunction  

Event Description

On (b)(6) 2011, it was identified by the maquet sales and service technician that the rpm knob on the rotaflow (unknown serial number) is completely broken now.The maquet sales and service technician identified this event on mcs lab day.The maquet sales and service technician noted that this could be the reason as to why the customer could not get the pump to start again after adding more paste.The maquet sales and service technician also noted that he attempted to turn the knob and the pump would not start.This event (rpm knob is completely broken) did not occur during use.(b)(4).

Manufacturer Narrative

(b)(4).Attempts were made to obtain additional information regarding this event.However, the attempts were unsuccessful and no additional information was obtained.(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt, ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEM, USA; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4285643
• MDR Text Key: 21171843
• Report Number: 8010762-2014-00532
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00952291
• Device Catalogue Number: 70102.2161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2011
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2011
• Date Manufacturer Received: 10/18/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1