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

Model Number ROTAFLOW CONSOLE

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A maquet field service engeneer (fse) evaluated the device.The maquet fse controlled the battery runtime and after 90 minutes running on battery, the rotaflow console displayed [bat 24.4].According to the ifu (instructions for use): "[.] under normal load and with fully charged, new batteries, and a flow rate of 5 lpm, the rotaflow system can be operated for at least 1.5 hours with the battery back-up.[.]" "[.] if the voltage drops to 20 v, there is only power left for a very short time.At a voltage of 19 v the system switches off automatically.[.]" "[.] battery voltage between 27.4 (fully charged) and 20.0 v [.]" the status display shows the following format for the charge indikation: "[.] status display: [bat xx.X] [.]" according to the performed test run of the battery, it can be concluded that the battery did not malfunction.In addition the fse noticed intermittent failures on the rotaflow drive that lead to the display of the error message "[error! head]".According to the ifu the error message "[error! head]" is leading to an accoustic alarm as well as to a pump stop.This would also explain the pump stop the user experianced.The console was fully functional using another rotaflow drive.The rotaflow drive in question was requested to be sent to the manufacturer for further evaluation and repair.A supplemental report will be provided if additional information becomes available.

Event Description

It was reported that during the transfert of a patient, the rotaflow stopped.This patient had been under ecmo (extracorporeal membrane oxygenation) for 40 days when the event occurred.Additional information received on 2016-01-19: there were no clinical consequence for the patient reported.The product was not replaced.There was no delay and no additional intervention was done.The pump was plugged in untill the start of the transport.The medical staff did not check if the battery was charged.The transport lasted less than 20 minutes.(b)(4).

Manufacturer Narrative

On (b)(6) 2016 01:16 pm (gmt-4:00) added by (b)(6) ((b)(4)): during the evaluation of the device by the manufacturer the reported error message "error head" could not be reproduced.The rotaflow drive was successfully tested to manufacturer specifications and no malfunction of the device could be confirmed.Based on the available information to the manufacturer at this time the complete rotaflow system (console including the battery and the drive) were successfully tested to manufacturer specifications and no malfunction of any component of the device could be confirmed.The actual cause for the reported event cannot be determined.All components of the system are performing as specified.

Event Description

On (b)(6) 2016 12:59 pm (gmt-4:00) added by (b)(6) ((b)(4)): (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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5413273
• MDR Text Key: 38154470
• Report Number: 8010762-2016-00066
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

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: 70103.6210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR