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

Model Number 560BCS1

Device Problem Decreased Pump Speed (1500)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

The bio-console instrument was returned and the reported clamp malfunction error was verified during service.Medtronic service found the 5 volt on the system controller was out of specification (read 4.991 v, spec.= 5.000 v +/-.002 v).The issue was resolved by calibrating the 5 volts to 5.0004 v.Functional testing was performed per specifications with no issues noted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use the bio-console instrument displayed a clamp malfunction error, the rpm knob value was set to 0 and multiple malfunction alerts were displayed.The instrument was changed out with a backup and there was no resulting adverse patient effect.Additional information was received confirming that the handcrank was used while the instrument was changed out with a backup.Customer reported that the flow was not significantly affected, but the error message was continuously generated.

• 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: 7826586
• MDR Text Key: 118557357
• Report Number: 2184009-2018-00026
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00643169315822
• UDI-Public: 00643169315822
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 08/29/2018

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: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention