MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-CAL 370; SYSTEM, THERMAL REGULATING

Model Number 95161-000

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

The service technician replaced the level sensor to resolve the issue.The removed level sensor was returned to medtronic.Laboratory analysis of the component could not conclusively determine the type of water that had been used in the bio cal.Medtronic requested additional information regarding the water source and cleaning protocols the facility was using with the bio cal, but no response was received.

Event Description

Medtronic received information reporting that during preventive maintenance by a field service technician, the heating element on this biocal heater/cooler was not functioning.There was no patient involvement in the event.Medtronic requested additional information regarding the water source and cleaning protocols the facility was using with the bio cal, but no response was received.

• Brand Name: BIO-CAL 370
• Type of Device: SYSTEM, THERMAL REGULATING
• 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: 6180716
• MDR Text Key: 62682087
• Report Number: 2184009-2016-00043
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95161-000
• Device Catalogue Number: 95161-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1