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

Model Number MCP00703171

Device Problems Pumping Stopped (1503); Low Battery (2584)

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

Event Date 09/23/2014

Event Type  Injury  

Event Description

It was reported that a patient was going to be moved to another department so the device was unplugged from the main electrical line.Within five minutes, the device battery alarm sounded and then the unit turned off.The unit was immediately plugged back in and replaced with another unit.There was no reported patient effect.(b)(4).

Manufacturer Narrative

The device was investigated by a maquet field service technician.The battery was found to be defective and was replaced.A supplemental medwatch will be submitted when additional information becomes available.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIPULMONARY YPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastattq 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4199704
• MDR Text Key: 5044101
• Report Number: 8010762-2014-01058
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention