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

Model Number 95161-000

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

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 received additional information indicating that the ice used in the instrument is derived from tap water.Bleach is run through the bio cal as part of the cleaning process.Per the operator's manual, tap water and bleach should not be used in the bio cal.

Event Description

Medtronic received information that during setup, the customer observed that the bio cal instrument was exhibiting high current leakage.The instrument was replaced with a backup and there was no resulting adverse patient effect.The facility biomed determined that the current drain was related to the heating element and requested field service.Medtronic received additional information indicating that the ice used in the instrument is derived from tap water.Also, bleach is run through the bio cal as part of the cleaning process.

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: 6181186
• MDR Text Key: 62682153
• Report Number: 2184009-2016-00044
• 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: 12/08/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/1994
• 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