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

Model Number 95161-000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.The device has reached end of life and is no longer maintained or serviced.Medtronic received additional information indicating that the water used in the device is produced from a filtered source.Per the operator's manual, de-ionized water should be used in the bio cal.

Event Description

Medtronic received information that the temperature on this bio cal continuously increased during testing.The instrument was replaced with a backup unit and there was no adverse patient effect.The medtronic field service technician informed the customer that this instrument is no longer serviced by medtronic and provided the customer the end of service letter.Additional information was received indicating that filtered tap water is used in the instrument.Per the operator's manual, de-ionized water should be used in the bio cal.

Manufacturer Narrative

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

• Brand Name: 370 BIO-CAL
• 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: 6182856
• MDR Text Key: 62682188
• Report Number: 2184009-2016-00047
• 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,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• 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
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: No
• 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