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

Model Number ROTAFLOW CONSOLE

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a rotaflow that failed over the weekend.According to the nurses in the icu, the console stopped working.When the perfusionist arrived, they were handcranking.The console read ¿error¿ across the screen and wouldn¿t reboot.Also, the black plastic gate over the flow sensor needed to be replaced.The unit was changed out with another console.No harm to the patient was reported.(b)(4).

Event Description

(b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

The defective power supply board was requested to determine the probable root cause in our life cycle engineering.The defective power supply board of the rfc was investigated in the lce on 2018-08-06 with following result: a defect was located on the power supply board.The mosfet t6 has a short circuit between drain and source.This causes the on-off-switch to be without function.The most probable root cause is a defective rotaflow drive.This is also the most probable root cause for the described error message ¿error-head¿.This head error was handled in tw complaint (b)(4).The most probable root cause is a defective rotaflow drive.This defective rotaflow drive was investigated in (b)(4).Thus the failure could be confirmed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.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.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- maquet medical systems usa (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: 7268992
• MDR Text Key: 100268501
• Report Number: 8010762-2018-00055
• 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,Followup
• Report Date: 02/21/2018

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: 701051712
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 01/29/2018; 01/29/2018
• Supplement Dates FDA Received: 02/21/2018; 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1