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

Model Number ROATFLOW DRIVE

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).A supplemental medwatch will be submitted after new information has been received.The emtec service technician investigated the defected device with the rma (b)(4) on the 20th february 2019.The failure could be confirmed.Therefore the electronic circuit boards and hedl (end coding module) were exchanged.Rotaflow drive has passed all tests.See also investigation with the same error in (b)(4): this error was induced by a hot plug.This happens when the drive was disconnected from a running rotaflow console.According to the ifu of maquet: "the rotaflow console must be switched off before the rotaflow drive is connected or disconnected." the most probable root cause of this error: "mishandling." thus the failure could be confirmed but it is no product related malfunction of the device.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).On 2019-02-25 after receiving new information: a head error occurred when rpm > 1000.

• 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: 8389993
• MDR Text Key: 141478508
• Report Number: 8010762-2019-00060
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROATFLOW DRIVE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• 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