MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP

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

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Reference importer report (b)(4).

Manufacturer Narrative

(b)(4).Maquet provides product failure investigation, analysis and resolution for the device described in this report.A supplemental medwatch will be submitted if additional information becomes available.Reference exemption number (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP
• Type of Device: ROTAFLOW
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strabe 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3787554
• MDR Text Key: 16552024
• Report Number: 8010762-2014-00179
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• 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
• Remedial Action: Other
• Type of Report: Initial

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?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1