MAUDE Adverse Event Report: PERFUSION SYSTEMS "MOTOR BIOCONSOLE EXT.DR MOTOR,54"; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 95120-003

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

Medtronic received information reporting that during use of this external drive motor with a 560 bio-console, the revolutions per minute (rpm's) of the drive motor suddenly went to maximum speed after turning the unit on.This occurred just as the patient cannulation was about to start, after the circuit was primed.It was further reported that after ramping up to maximum, the rpm's then went to the speed set by the user.This sequence of events occurred repeatedly, with the external drive motor rpm's going to zero and causing loss of pump flow.It was also reported that the motor speed did not respond to adjustment of the rpm knob.The external drive motor was changed out with a standby unit, prior to cannulating the patient, and the procedure was then completed with no further issues noted.There was no resulting adverse patient effect associated with the event.The product was returned to the u.S.Cv-sh service depot for analysis.

Manufacturer Narrative

The product has been received in medtronic's u.S.Service depot for analysis.Analysis and investigation are planned, but have not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Manufacturer Narrative

Testing of the external drive motor with the 560 bio-console in the medtronic u.S.Service depot was unable to duplicate the reported revolutions per minute (rpm) motor speed issue.However, review of the instrument¿s event data log confirmed the occurrence of the reported event and instances of error 47, 49, and 52.Based on the information provided, the issue seemed to have been caused by an intermittent function of the hall effect sensor or related parts.However, since the issue could not be duplicated, the root cause could not be confirmed.Preventive maintenance and performance testing of the instrument was performed with no problems detected.Details of the event data log review include the following: the data indicated that the motor tachometer elevated to maximum rpm although the rpm setpoint was set at a lower threshold.During each of these occurrences, error code 47, 49, or 52 also occurred.The duration of the tachometer excursion was extremely short (approximately 1 second on and 3 seconds off) and does not appear to have changed the flow rate profile.Additionally, the device history was reviewed.No anomalies were noted during the review of the dhr.The unit met all functional and performance testing requirements prior to release to distribution.The specific behavior in this complaint has not been observed previously.A review of customer complaints from (b)(6) 2011 to (b)(6) 2015 for this same failure mode was completed.Six other complaints were found over this time frame.The investigations found that various failure modes had been identified as the root cause.At this time there is not trend of complaints.(b)(4).

Event Description

Medtronic received information reporting that during use of this external drive motor with a 560 bio-console, the revolutions per minute (rpms) of the drive motor suddenly went to maximum speed after turning the unit on.This occurred just as the patient cannulation was about to start, after the circuit was primed.It was further reported that after ramping up to maximum, the rpms then went to the speed set by the user.This sequence of events occurred repeatedly, with the external drive motor rpms going to zero and causing loss of pump flow.It was also reported that the motor speed did not respond to adjustment of the rpm knob.The external drive motor was changed out with a standby unit, prior to cannulating the patient, and the procedure was then completed with no further issues noted.There was no resulting adverse patient effect associated with the event.The product was returned to the u.S.(b)(4) service depot for analysis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: "MOTOR BIOCONSOLE EXT.DR MOTOR,54"
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4854835
• MDR Text Key: 5873238
• Report Number: 2184009-2015-00014
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K941921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95120-003
• Device Catalogue Number: 95120-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other