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

Model Number MCP00706053

Device Problem Device Inoperable (1663)

Patient Problem Convulsion, Tonic (2223)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As stated by the customer during patient treatment the rotaflow unit connected to a hl20 went into battery mode and suddenly stopped working.The patient woke up convulsing, presenting neurological problems and runs the risk of death.Patient`s status after the incident: sedated patient with good gas exchange, she was been using mechanical ventilation since the incident.(b)(4).

Manufacturer Narrative

The unit will not be returned to maquet for investigation as it is already back in use.The unit has been investigated by a field safety technician.According to the service order (b)(4): the equipment was on free mode on all rollers and on the rotaflow (with the safety interventions disabled).The load tests, battery mode and interventions are ok.It was recommended a new clinical applications are ok.Full functional and safety test passed.All tests were performed to determine the failure but the equipment worked properly.Afterwards the device went back to customer.The failure could not be reproduced cannot be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigations will be completed at this time.

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: 6170479
• MDR Text Key: 62253101
• Report Number: 8010762-2016-00720
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K123510
• 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
• Report Date: 03/16/2017

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: MCP00706053
• Device Catalogue Number: 701043298
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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