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

Model Number ROTAFLOW PUMP MODUL

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem Death (1802)

Event Date 10/28/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The device has bee requested but not received.A review of the instructions for use (ifu) was performed and the available information was evaluated by the clinical specialist.According to the ifu when the rotaflow is switched on, the rotaflow-console automatically performs a self-test and displays various messages.When the display shows the message ¿valve¿ the user is requested to confirm that suitable systems or methods are available to prevent a reverse flow (e.G.A valve or two tube clamps) by pressing the ¿clamp¿-button.Therefore it can be concluded that when the ¿valve¿-message appears, there was either an interruption in the electrical power supply or the device was switched off, since the ¿valve¿-message is only displayed during the self-test procedure on start-up of the device.The message ¿valve¿ itself doesn¿t lead to a pump stop.The manufacturer was not provided with the requested information if these steps were followed accordingly to the ifu.Based on the available information at this time a malfunction of the device, leading to the suspected shut-down of the device cannot be excluded.Therefore the device is needed for evaluation.The information at this time does not allow a sufficient evaluation of the course of the event and if the appropriate measures were taken.A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that a patient was on a rotaflow pump since (b)(6) 2015.On (b)(6) 2015 the perfusionist noticed that the device was alarming, displaying "valve".The perfusionist attempted several times to clear the error without success.He attempted to power down the unit and to reboot but the "valve"-message still did not clear.He then began to handcrank, using the emergency-drive-unit.The patient began to decompensate which progressed to cardiac arrest.The patient was transferred to an ecmo circuit for support.On (b)(6) 2015 information was provided that the patient expired.The actual date of death as well as the surrounding circumstances have not been provided but it was reported that it appears to have been shortly after the incident.(b)(4).This complaint is related to facility mdr#: 0039-0111-2015-0005.

• 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): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5240966
• MDR Text Key: 31782681
• Report Number: 8010762-2015-01190
• 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
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW PUMP MODUL
• Device Catalogue Number: 70105.1712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2015
• Distributor Facility Aware Date: 10/28/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2015
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/20/2015
• Date Device Manufactured: 11/01/2015
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 53 YR