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

Model Number ROTAFLOW CONSOLE

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 10/08/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

(b)(4).On (b)(6) 2017 the device has encountered a problem and the pump stopped during the operation.Error!! -12v was shown on the display.Hospital staff did not proceed to manual operation, they informed the perfusionist, he went to the hospital as soon as possible.He tried, with the help of other percussionists(from other hospitals) to proceed with restarting the device.Patient was connected to ventilator and had a very good heart function.Patient died 3 hours later from bleeding in lungs.

Manufacturer Narrative

The defective power supply board and flow measure board were sent for investigation to the life cycle engineering to (b)(6).Result: capacitor c107 on the flow measuring board caused a large increase in current in -12 v path due to a partial breakdown, which triggered f3 fuse on the power supply board.The cause of the defect of capacitor c107 cannot be determined.Shocks are possible when transporting the rotaflow console.The clinical assessment of the incident will follow.A supplemental medwatch will be submitted after new information has been received.

Event Description

(b)(4).

Manufacturer Narrative

(b)(6).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).Information of our therapy application manager: all the required points were examined.The rotaflow has done as it should.When the alarm appeared, the device turned off for security.Information of the (b)(6): the distributor stated that the parents were told the death occurred because of lung problems not because of the machine.The customer also did not correlate the malfunction with the death.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this as a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.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: 6958252
• MDR Text Key: 89614760
• Report Number: 8010762-2017-00339
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701051696
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Date Device Manufactured: 03/01/2016
• 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