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

Model Number ROTAFLOW DRIVE

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

Patient Problem Death (1802)

Event Date 01/06/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the rotaflow drive quit working during patient treatment.Customer put another drive on the rotaflow console and all worked, no issues with the console.Perfusion department confirmed the event date (b)(6) 2017.And it was also reported that the patient had a brain bleed and was take off life support and passed away.Time of death 13:08 on (b)(6) 2017.(b)(4).

Manufacturer Narrative

A request has been made for the return of the device on 31-01-2017.The ssu contact informed us that the device would be available from 02-02-2017.On the 22-02-2017 another request was sent for the return of the device.However, the device has not yet been returned from the customer.More follow will be made for the return of the device.As no proper information was provided regarding the reported incident, thus no risk analysis could be determined.The only information reported was that an error occurred and that the device ¿quit working¿.No further details regarding the error were provided.Also no analysis could be determined if there were any previous mdrs related to this reported incident.No software changes were made to the device since 1998 as confirmed with the regulatory department.At this time, no further actions can be taken until the device has been returned and investigated.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: 6260446
• MDR Text Key: 65082869
• Report Number: 8010762-2017-00011
• 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: 01/06/2017,02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE
• Device Catalogue Number: 701022161
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2017
• Date Manufacturer Received: 01/06/2017
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death