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

Model Number ROTAFLOW DRIVE UNIT

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that on start up of device the error message "head" occurred.No patient involvement or harm was stated.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).

Event Description

(b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002 importer- (b)(4).The defective rotaflow drive was sent to germany with rma# (b)(4) for further investigation at the supplier em-tec.According to the service report# rma#2018-10184 dated on 2018-07-19 following was found: the failure could be reproduced.The defective ila 213 was replaced as well as the ball bearing was replaced.Burnin, calibration and final check system test were performed according to the service protocol.The rotaflow drive unit passed all tests.The most probable root cause could be determined as mishandling and/or aging.Thus the failure could be confirmed.In the course of the investigation of nc-17-06-011 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.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7669672
• MDR Text Key: 113642421
• Report Number: 8010762-2018-00225
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2018

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 DRIVE UNIT
• Device Catalogue Number: MCP0.0952291
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 06/12/2018; 06/12/2018
• Supplement Dates FDA Received: 07/31/2018; 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1