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

Model Number 560BCS1

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

The product has been received in medtronic service.The analysis and investigation is in progress.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.

Event Description

Medtronic received information that during use the external drive motor on this bioconsole instrument had a louder noise than usual and the bioconsole instrument displayed error codes.The procedure was temporarily performed by using the hand crank while the external drive motor and bioconsole instrument were replaced.There were no adverse patient effects.

Manufacturer Narrative

Product analysis: the reported error codes were not duplicated during service however the reported error codes were verified as the error codes were listed in the event log.The motion pressure (mp) module was replaced as a precautionary measure.After the service the device was tested and performed within specifications a review of the device history record for this device confirmed that no anomalies were observed during manufacturing.A review of complaints identified no current trends.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Medtronic received information that during use, the external drive motor on this bio-console instrument had a louder noise than usual and the bio-console instrument displayed error codes.The procedure was temporarily performed by using the hand crank while the external drive motor and bio-console instrument were replaced.There were no adverse patient effects.

• Brand Name: BIO CONSOLE 560
• Type of Device: CONTROL, 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 Key: 6748883
• MDR Text Key: 81244321
• Report Number: 2184009-2017-00028
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2010
• 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): Required Intervention