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

Model Number ROTOFLOW DRIVE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(4).A "head error" occurred on the rotaflow when > 1000 rpm during startup of device.No patient involvement.

Manufacturer Narrative

A supplemental medwatch will be submitted after new information has been received.Device code: 1198.The rotaflow drive with the rma 2019-10121 was invested by emtec on the 2019-06-04: the unit occurs an error message "head" in the status display.It occurs when to rise the rpm over 1000 rpm.The described failure of the customer could be confirmed.It was noticed that the ild(optocoubler)was defective and the locking wheel on the mast holder is broken.Therefore the ild and the locking wheel on the mast holder were exchanged.Rotaflow drive has past all tests.Root cause: mishandling the rotaflow drive was also investigated at the getinge service technician with the maquet service order report# (b)(4) and rma# (b)(4) on the 2019-07-16: problem description: error message "head".Work performed: ild replaced.-looking wheel on the mast holder replaced system test performed according to service protocol.The rotaflow was also investigated at the getinge service technician with the maquet service order report # (b)(4) and rma# (b)(4) on the 2019-07-17: problem description: error message "head".Work performed: -on-off switch replaced,control board replaced.-flow measuring board replaced (see complaint# (b)(4), rfc display board replaced,rotaflow sealing kit replaced.System test performed according to service protocol.For this error an nc was opened and investigated: 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.Corrected address: (b)(6) south korea.

Event Description

Internal reference:(b)(4).Autonumber: one support# (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
• MDR Report Key: 8373745
• MDR Text Key: 141338387
• Report Number: 8010762-2019-00053
• 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
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

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: ROTOFLOW DRIVE
• Device Catalogue Number: 9100108538
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1