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

Model Number ROTAFLOW CONSOLE

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 10/28/2017

Event Type  Death  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that on the rotaflow console during treatment, "----" occurred on flow display when rpm was more than 2500, there was flow value when rpm was below 2500.The customer reapplied ultrasonic contact cream, same as above description.The patient was dying.They transfer centrifugal pump to emergency drive.Patient was dead at the end.Fse of maquet china checked this device with test tube in hospital.Flow measurement was normal.The device is not available to send back for investigation.Article number of rfd: (b)(4).Sn of rfd: (b)(4).Rfd is not available for investigation.The disease of this patient is pulmonary fibrosis.The customer didn't provide extra information to us till now.They had used the emergency drive about 1 hour.Drive and console were not exchanged during treatment.The failure occurred again when using the test tube.Fse found bubble in test tube.After getting rid of bubble, no failure.Internal reference: (b)(4) onesupport #(b)(4).

Manufacturer Narrative

The device in question was not available for further investigation.According to the service order of the field service technician "the device was checked with test tubes in hospital.And the pump been running for two hours, no failure detected.Flow measurement was normal.The device was checked and cleaned for clinical use.Our therapy application manager created a clinical complaint analysis for this case with the following conclusion: according to the received information it can be considered by process of elimination of possible root causes that rotaflow console was operating as specified and the ultrasonic crème was not dried out.Because of lack of information it is not possible to figure out the root cause of the incident.Thus the failure could not be confirmed.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.Due the failure could not be reproduced no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.

Event Description

Internal reference: (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: 7004012
• MDR Text Key: 91123722
• Report Number: 8010762-2017-00355
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• 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: 701046405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2017
• Date Device Manufactured: 06/01/2017
• 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