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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS MOTOR EXTERNAL DRIVE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS MOTOR EXTERNAL DRIVE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 560A
Device Problems Pumping Stopped (1503); Contamination /Decontamination Problem (2895); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
Event Type  Injury  
Manufacturer Narrative
The bio-console external motor drive instrument was analysed by medtronic service and the reported noise and foreign material were not verified during service. Medtronic service was not able to duplicate the noise issue with the external motor drive instrument. The service technician ran the external motor drive instrument attached in a flow loop for over an hour and no unusual noises were noted. During service when the connector was attached to the bio-console it was noted that the connector was bent. This caused the connector to bind when attached to the bio-console. The service technician removed the magnet cover and found that the magnet had rubbed on the magnet cover. The magnet depth was within specification. The instrument will be scrapped due to the damaged connector as it is not possible to refurbish the damage. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of this bio-console external motor drive and a non-medtronic power supply a humming noise was noted to be coming from the external drive motor. The noise started to get progressively louder, but rpm and arterial flow remained unaffected and there was high voltage error. The customer requested a backup external drive motor and got a hand crank ready. The customer assumed decoupling of the drive motor and centrifugal pump, because of the noise, and the customer was about to clamp, come off cardiopulmonary bypass (cpb), and turn rpm to zero to "recouple". As soon as the perfusionist was about to do this, the drive motor failed, and the noise went away. Rpm was at zero on the workstation but reading "!!!" on the non-medtronic power supply, backflow was observed on the arterial line due to no rpm. The customer was unable to control the rpm in any way and hand cranking was started. While the perfusionist was hand cranking, the external drive motor was unplugged from port 13, plugged it into port 1 4, reconfigured the arterial pump for location 14 in admin mode, and the customer was able to regain control of the rpms. Hand cranking was stopped, and the case was finished without issue. After bypass, when the patient was stable and safe, but before powering off the external motor drive and non-medtronic power supply, the customer tried to reconfigure to port 13 and see if they could control the rpm but the issue persisted. The customer put the external motor drive back into port 14 and reconfigured in case they needed to re-use the external motor drive and non-medtronic power supply or go back on cpb. The customer noticed the noise after being on cpb for approximately 30 to 40 minutes. The patient was undergoing a triple coronary artery bypass grafting procedure. No issues were observed during priming, initiation of cpb or during cpb up until this point. The customer had used the same equipment for two full days without any issues in wet lab/training. The customer stated that when the external motor drive was unpacked, they noticed that there was a residue on it. The customer wiped off the residue before connecting the external drive motor to the non-medtronic power supply.
 
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Brand NameMOTOR EXTERNAL DRIVE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer (Section G)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key9860296
MDR Text Key190333368
Report Number2184009-2020-00018
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100631
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number560A
Device Catalogue Number560A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/20/2020 Patient Sequence Number: 1
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