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

Model Number ROTAFLOW CONSOLE

Device Problem Loss of Power (1475)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).As stated by the (b)(4): "the getinge fse tried again to investigate the affected rotaflow yesterday ((b)(6) 2019).The device is still connected to the patient.Please note that the patient still connected to the device is the patient involved in the complaint.The getinge fse could intervened on the device on (b)(6) 2019.Here is the translation of the service report: description: rotaflow device sn (b)(4).Failure: device suddenly stopped during use on patient.Work done: check of the battery and power supply lamps, on/off button ok, check of the alarms (switch to battery, low battery, speed and flow out of limits) ok, running test on battery during 2 hours, ok, functional test ok, electrical test ok.Thus the failure could not be confirmed.As the problem occurred when moving the patient and the console was used without any other problem during 10 days after the event, we think that it must be related to a problem of use.".

Event Description

(b)(4).According to the hospital (translation of the (b)(6) report): "description of the event: patient under ecmo.Sudden occurence of bradycardia with profound hypotension.Stop of the observed while the console is plugged into the main supply, no problem of connection or charge of the battery.Restart of the console after the emergency drive was used and by pressing on the on/off switch.Latest maintenance 15-nov-2018.Current state of the patient: cardiac arrest.Resuscitation.Actions implemented by the health facility for patient care: quarantined of the console before expertise by the manufacturer.".

• 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: 8305049
• MDR Text Key: 135005779
• Report Number: 8010762-2019-00025
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701036210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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): Life Threatening; Required Intervention