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

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.

Manufacturer Narrative

The reported noise and foreign material were not initially verified during service.The foreign material had been cleaned prior to use and prior to sending the device to medtronic for service.However, medtronic can confirm similar incidents of a sticky substance (capa (b)(4)) on neighbouring serial numbers and therefore is confirming the foreign material on this device although service was unable to duplicate the noise, service analysis found evidence of interference between the ap40 pump and 560a motor drive which is believed to have caused the noise observed by the customer.At this time is unknown what caused the interference as the ap40 pump was not returned.Review of the devise history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Medtronic will continue to monitor for future occurrences and trends per the product quality meetings medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOTOR EXTERNAL DRIVE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 9860296
• MDR Text Key: 190333368
• Report Number: 2184009-2020-00018
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00763000108281
• UDI-Public: 00763000108281
• Combination Product (y/n): N
• PMA/PMN Number: K100631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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 Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560A
• Device Catalogue Number: 560A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 116