MAUDE Adverse Event Report: PERFUSION SYSTEMS 560BC BIO CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 560BC

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  Injury  

Event Description

Medtronic received information reporting that during use of a 560 bio-console in a percutaneous cardiopulmonary support (pcps) procedure, the motor drive operation did not function as expected.After approximately four days on pcps, the bio-console low flow alarm sounded and the flow rate was indicated as 0; however, the pump rotation speed was indicated as a normal value of 2200 revolutions per minute (rpm).The connection and attachment of the flow sensor component was verified, but the situation did not improve and the blood in the tubing reportedly started to separate.The kyocera gyro blood pump was switched over to a hand crank device so that the rotation of the concomitant gyro pump external motor drive could be evaluated.During use of the hand crank device, the bio-console 560 was completely turned off, and then the external motor, flow sensor, and cables were removed and reconnected.These activities took approximately ten minutes and afterward the whole system returned to normal operation.The kyocera gyro pump was reinstalled into the gyro pump¿s motor drive with no resulting adverse patient effect.There was no further issue reported with the 560 bio-console; however it was later replaced with a 550 bio-console so that it could be returned to the medtronic japan service <(>&<)> repair center for evaluation.

Manufacturer Narrative

The reported flow issue could not be duplicated during analysis of the returned bio-console and concomitant products in the medtronic japan service <(>&<)> repair center.The reported issue did not repeat and no abnormality was observed during operational/functional testing of the instrument.The medtronic service engineer replaced the following 560 bio-console motor control related parts as a precautionary measure: rpm potentiometer cable assembly ((b)(4)), syscon board assembly ((b)(4)), m/p module assembly ((b)(4)), user interface cable assembly ((b)(4)), and the bitsy xb board assembly ((b)(4)).The dirty fan filter was replaced and instrument inspection and calibration was performed.Final testing confirmed the bio-console instrument functioned normally.It was also noted that the following 540k kyocera external drive motor parts were replaced as precautionary measure: cable set ((b)(4)) and dc motor ((b)(4)).Final testing of both the 540k external motor and tx-50 flow transducer accessory devices confirmed they functioned normally.Analysis of the instrument data log by a medtronic quality engineer noted the data indicated that the flow may have stopped, but the motor continued to run (as was shown by the revolutions per minute display).Possible reasons for this condition could have been unintentional dislodgment of the pump or the occurrence of an occlusion in the circuit (accidental clamp, kink in the tubing, etc.) neither of these possibilities were reported in the event description.The customer reported that the instrument continued to function as expected after they rebooted the instrument and disconnected and reconnected the cables; however, there was no indication of the instrument being turned off during this time in the instrument data log.(b)(4).

Event Description

Medtronic received information reporting that during use of a 560 bio-console in a percutaneous cardiopulmonary support (pcps) procedure, the motor drive operation did not function as expected.After approximately four days on pcps, the bio-console low flow alarm sounded and the flow rate was indicated as 0; however, the pump rotation speed was indicated as a normal value of 2200 revolutions per minute (rpm).The connection and attachment of the flow sensor component was verified, but the situation did not improve and the blood in the tubing reportedly started to separate.The kyocera gyro blood pump was switched over to a hand crank device, so that the rotation of the concomitant gyro pump external motor drive could be evaluated.During use of the hand crank device, the bio-console 560 was completely turned off, and then the external motor, flow sensor, and cables were removed and reconnected.These activities took approximately ten minutes and afterward the whole system returned to normal operation.The kyocera gyro pump was reinstalled into the gyro pump¿s motor drive with no resulting adverse patient effect.There was no further issue reported with the 560 bio-console; however, it was later replaced with a 550 bio-console, so that it could be returned to the medtronic (b)(4) service <(>&<)> repair center for evaluation.

Manufacturer Narrative

The product was received in medtronic's (b)(4) service <(>&<)> repair center for analysis.The analysis and investigation are in-progress at this time.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Manufacturer Narrative

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

• Brand Name: 560BC BIO CONSOLE
• 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: 4111623
• MDR Text Key: 5177303
• Report Number: 2184009-2014-00075
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080824
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2014

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: 560BC
• Device Catalogue Number: 560BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided; 12/05/2014
• Supplement Dates FDA Received: 12/18/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: GYRO PUMP
• Patient Outcome(s): Required Intervention