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)

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

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Field safety engineer has been sent for investigation.The device has been troubleshooted and inspected.The error could be confirmed.Therefore the flow measure board of the rotaflow console was exchanged.Electrical safety tests to factory specifications was successfully.For further investigations the defected flow measure board will be investigated here in (b)(6).A supplemental medwatch will be submitted after new information has been received.

Event Description

During patient support the rotaflow had an "head error" with pump stop.The patient was isolated from the rotaflow console with tubes clamp.The rotaflow console and drive motor were changed to a back-up rotaflow system.No known impact to the patient was reported.(b)(4).

Manufacturer Narrative

For further investigation the defective flow measure board was investigated by the life cycle engineer in germany most probable root cause: the claimed error message "error head" could not be observed.Initially, the flow measuring board examined caused the error message "del error".Its cause could not be fully determined because the error disappeared during the study and was no longer observed.The most probable cause of failure is a defect of the select line which forwards the signals of the delay line to the receive amplifier.A supplemental medwatch will be submitted after new information has been received.

Event Description

(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 ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6554016
• MDR Text Key: 74897370
• Report Number: 8010762-2017-00148
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

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: 701043292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 04/17/2017
• Supplement Dates FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1