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

Model Number ROTAFLOW CONSOLE

Device Problem Loss of Power (1475)

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

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A maquet field service technician evaluated the device and was able to confirm that the battery was discharging on a very fast rate.In addition information was provided that the hospital staff usually plugs the unit into an old power strip while not in use.It was highly recommended to the staff that the unit gets plugged directly into ac outlet.The claimed battery was replaced.The units charging circuit was verified as functional by checking the voltage on newly installed battery and charging for 1 hour.Voltage before charge 24.4 vdc.After charge 27.4.All led's pertaining to charging circuit function properly.The unit was successfully tested to manufacturer specifications and returned to service.The defective battery was requested to be returned to the manufacturer for further investigation.A supplemental report will be provided if additional information becomes available.

Event Description

It was reported that the patient was in the process of being transported to a hybrid room while on the rotaflow.As soon as unit was unplugged the unit shut off.The unit had to be plugged back in until a spare unit could be used for transport.No patient harm was reported.(b)(4).

Manufacturer Narrative

(b)(4).A maquet field service technician replaced the battery , checked the device for functionality and returned the device to the customer ready to use.Although requested, the battery was not returned to the manufacturing site for further investigation.It has been scrapped.There was no patient injury or harm.

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: 5574304
• MDR Text Key: 43170550
• Report Number: 8010762-2016-00259
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701028708
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2005
• 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