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

Model Number ROTAFLOW DRIVE

Device Problem Loss of Power (1475)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

Mar.24, 2016 02:20 pm (gmt-4:00) added by (b)(6): (b)(4).A maquet field service technician (fst) evaluated the device.The battery was checked for its capacity and found to shut off after approximately 40 minutes at 3300 rpm (rotations per minute).Based on this result it was confirmed that the battery does not meet the manufacturer specifications and failed the battery run time test.The defective battery was requested to be returned for further investigation.The defective battery was replaced.Prior records show that the battery had been installed on (b)(6) 2014 which is within the maintenance instructions given by the manufacturer to replace the battery every 24 month.According to the ifu (instructions for use) the battery capacity needs to be checked every 6 month by performing a battery runtime test.The last checked for the battery run time was performed on (b)(6) 2015 which was over 6 month prior to the event and therefore does not meet the specified manufacturer instructions.A supplemental report will be provided when additional information becomes available.

Event Description

Mar.24, 2016 02:11 pm (gmt-4:00) added by (b)(6): it was reported that the patient was mobilized to stand up while on the rotaflow.The rotaflow was unplugged from the ac power to run on battery power.The rotaflow immediately shut off.The staff immediately plugged the rotaflow back into the ac power.It was reported that no harm or intervention to patient was required.No reported alarm before the device shut off.In addition it was reported that the battery capacity read 26v at the time the battery operation was initiated.(b)(4).

Manufacturer Narrative

(b)(4).A maquet field service technician replaced the battery due to insufficient run time.As the battery failed within the 2 year period, it was sent to lce for investigation.Following an investigation, no definitive root cause could be established as the battery had been deeply discharged and could not be recharged.The cause of the failure was most probably due to the user not following rotaflow ifu chapter 3.3.4 whereby the device should be plugged into the mains with the main circuit breaker on the "on" position when not in use for lengthy periods, particularly if the unit has been running on battery before storage.There was no patient injury or involvement.

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: 5525239
• MDR Text Key: 41540575
• Report Number: 8010762-2016-00214
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1