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U.S. Department of Health and Human Services

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

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PERFUSION SYSTEMS BIO-CAL 370; SYSTEM, THERMAL REGULATING Back to Search Results
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.
 
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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 Key6180716
MDR Text Key62682087
Report Number2184009-2016-00043
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894980
Number of Events Reported1
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 Number95161-000
Device Catalogue Number95161-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2016
Initial Date FDA Received12/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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