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

Model Number ROTAFLOW CONSOLE

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The device was investigated by a getinge service technician with summary report# (b)(4) on 2019-03-08: customer stated that there was a battery switching issue.Complaint# (b)(4).But this failure could not be confirmed by the technician.He found that there was an error issue with the unit while not pumping but rolling the unit down the hallway.The user then tried swapping out the drive with another.This cause the unit to start dis "error head" (see new complaint (b)(4) opened) once the rpm`s were above 1000rpm.After more inspection and troubleshooting the technician replaced the rfc control board.This solved the issue and the unit was to pass all performance and safety tests.The unit was approved for clinical use and returned to the customer.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).During patient transport the pump stopped.Therefore the user tried swapping out the drive with another.This caused the unit to start displaying an error head when > 1000rpm.No harm to the patient was reported.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• 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: 8461177
• MDR Text Key: 142644764
• Report Number: 8010762-2019-00082
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• 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
• Patient Outcome(s): Required Intervention