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 09/18/2016

Event Type  malfunction  

Manufacturer Narrative

Medtronic requested additional information regarding the water source and cleaning protocols the facility was using with the bio cal, but no response was received.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 the water pump on the bio cal heater/cooler instrument did not function.The timing of the observation was not specified, but the customer stated that there were no adverse patient effects as a result of the issue.The medtronic service depot technician informed the customer that this product is no longer serviced and provided the customer with the medtronic end of service letter.Medtronic requested additional information regarding the water source and cleaning protocols the facility was using with the bio cal, but no response was received.

Manufacturer Narrative

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

• 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: 6167829
• MDR Text Key: 62332613
• Report Number: 2184009-2016-00040
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: 12/06/2016
• Supplement Dates FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2008
• 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