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

Model Number ROTAFLOW CONSOLE

Device Problem Battery Problem (2885)

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

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

The field service technician (fst) was sent out for further investigation.According to the service report# (b)(4) dated on (b)(4) 2018 following was found out: while transporting patient battery voltage dropped and low battery alarm sounded.Device turned off.Customer plugged device into wall power and cycled power.Device powered up then turned off again.Patient was moved to another rotaflow.Patient remained stable.When biomed saw device the power cord wasn't plugged in all the way on the back of the rotaflow.Biomed reseated line cord and let battery charge to full.When the fst arrived he ran the device with a test loop 2500 rpm @ 8 lpm.The battery lasted 48 min which makes the 30 min spec.It looks like the root problem was that the power cord wasn't in all the way.Causing the device to run on battery when they thought it was plugged in.Also the reason the device wouldn't work when the customer thought they were supplying wall power when they weren't.Causing the device to shut down again quickly.Because the batteries are due next month customer requested that the fst goes ahead and replace them now.The fst replaced the battery pack ni-cd 24v 120wh (material# (b)(4), serial# unknown.Performed and passed all functional and safety tests.Released to customer for clinical use.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4) importer- (b)(4).

Event Description

It was reported that while transporting the patient the battery voltage dropped and low battery alarm sounded.Device turned off.Customer plugged device into wall power and cycled power.Device powered up then turned off again.Patient was moved to another rotaflow.Patient remained stable.When biomed saw the device the power cord wasn't plugged in all the way on the back of the rotaflow.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: 7985184
• MDR Text Key: 124663045
• Report Number: 8010762-2018-00283
• 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
• Report Date: 10/19/2018

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: ROTAFLOW CONSOLE
• Device Catalogue Number: 70105712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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): Required Intervention