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

Model Number ROTAFLOW

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During service/maintenance: rotation speed of rfc and rfd were different noise and "head error".Complaint# (b)(4).

Manufacturer Narrative

The rotaflow drive was investigated from an emtec technician with the service order report# (b)(4) on the 2019-07-24: during the in-house inspection, the drive made noise and head alarm occurred.When "head alarm" occurred, the output data from rs-232c was checked and noticed that the rotation speed on the console side and the rotation speed on the drive side were different.The rotation speed on the drive side was displayed low.Therefore the failure could be on the drive side.The error described by the customer could not be traced.In goods receipt it was noticed that the knurled nut on the mast holder is missing.After further testing it was noticed that the deep groove ball bearings are no longer 100% in order.Action: knurled nut attached.Replacing deep groove ball bearing.Rfd has passed all tests.Possible root cause: aging the device was also investigated from the getinge service technician with the maquet service order report# (b)(4) and customer order no: rma id (b)(4) on the 2019-07-26: additional work performed: investigation performed: missing knurled nut on must holder mounted (confirmed).Defective ball bearings replaced (confirmed).Burn in, calibration and final check.System test performed according to service protocol for this head error an nc was opened and investigated: 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.

Event Description

Complaint# (b)(4).

• 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
• MDR Report Key: 8631613
• MDR Text Key: 145764166
• Report Number: 8010762-2019-00131
• 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,o
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

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: ROTAFLOW
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 07/26/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1