MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number ROTAFLOW DRIVE

Device Problems Device Displays Incorrect Message (2591); No Flow (2991); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will be evaluated by a maquet field service technician.A follow-up medwatch will be submitted if additional information becomes available.

Event Description

It was reported that the rotaflow got the signal error.The unit was reset and the flow stopped and the device started making a noise.Additional information: the incident occurred during patient treatment, no negative consequences for the patient or a delay in therapy were reported.(b)(4).

Manufacturer Narrative

A maquet field service technician was on site and investigated the unit.The technician determined that the root cause is the drive unit.The console operated as it should.A supplemental medwatch will be submitted if additional informations becomes available.

Event Description

(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5893605
• MDR Text Key: 53600584
• Report Number: 8010762-2016-00534
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1