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

Model Number ROTAFLOW CONSOLE

Device Problems Device Operates Differently Than Expected (2913); Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The affected rotaflow unit (console and drive) has been requested to send back to germany for further investigation.(b)(4).A supplemental medwatch will be submitted after new information has been received.

Event Description

According to the customer: we have a rfc unit which seems to be with some problems.The value of lpm is not stable even not changing rpm.Not able to set zeroing.The tubing was clamped at that time.Lpm couldn't rise even turning rpm up.The tubing was not clamped and there was not any interruption at the moment.These issues was occurred at different time respectively, not same time.The device was exchanged with another unit during the procedure.No harm to the patient was reported.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).The affected rotaflow unit (console and drive) has been investigated with the following result: the console ran for 17 days in the workshop without any abnormalities.The error could not be reproduced.Since it cannot be ruled out that the drive will work properly, it will be sent to em-tec for further investigation.The affected rotaflow drive with serial number (b)(4) has been send to em-tec for investigation with the following result: according the em-tec report (b)(4) the drive was tested and no failure detected.The descripted failure could not be reproduced.The console was not been send to em-tec.The drive passed all test by the manufacturer.Both affected devices (rfc and rfd) was checked together with no failure.The console and drive was also tested according to the service protocol.Thus the failure could not be confirmed.The most probable root cause could not be determined, because the failure was not reproducible.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.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 is a systemic error.No corrective action is needed.

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: 7079210
• MDR Text Key: 93859041
• Report Number: 8010762-2017-00378
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701043290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 04/16/2018
• Date Device Manufactured: 06/01/2016
• 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