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

Model Number ROTAFLOW CONSOLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

The field service technician (fst)was onsite for further investigation.According to the service report# (b)(4) dated on 2018-11-14 following was found: the fst observed the system and duplicated the error.The fst troubleshot the system and determined the control board was defective and replaced the control board (material# 701034051, serial# (b)(4)).Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.In the course of the investigation of (b)(4) all complaints were analyzed individually to look for patterns and causes.After evaluation of the complaints, the following defects are the most common: hot plug, sig error followed by head error, error message due to shaking / error message due to sensitivity, connection problems and hardware-error.The increase in complaints with the error "head error" is due to a user/application error.The actions have been addressed in the past to prevent application errors.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manual, mcv-ga-10000703-de-11, contain detailed descriptions to prevent an "error head".In addition, the instruction manual describes how the user has to react in case of an error message so that the application can be continued if possible.Since there are several causes of errors that result in an error head (error head) message, no final root cause could be determined.It is noticeable that the evaluated error is largely due to a user error.Warning in the ifu regarding "hotplug" and label with the "hotplug" warning on the rfc have already been implemented in the past.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that the customer stated the rotaflow console would display a head error while priming the system.No patient involvement.(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: 8130069
• MDR Text Key: 129885963
• Report Number: 8010762-2018-00318
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2018

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: ROTAFLOW CONSOLE
• Device Catalogue Number: MCP0.0702697
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2004
• 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