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U.S. Department of Health and Human Services

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

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PERFUSION SYSTEMS "370, BIO-CAL" SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 95161-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/01/2015
Event Type  Injury  
Manufacturer Narrative

The product will not be returned to medtronic's u. S. Service depot for analysis. Investigation is planned, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).

 
Event Description

Medtronic received information that a patient who underwent an aortic valve replacement along with 3 vessel cabg later presented with a bacterial infection. Approximately 5 months post procedure, the patient tested positive for mycobacterim abscessus. The patient had no prior history of infection. The patient had a non-healing sternal wound and osteomyoletis. The patient was sent home on iv antibiotics. The biocal heater/cooler instrument used for this procedure was initially pulled out of service by the facility, but has since been sterilized by the facility and returned to use.

 
Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation. The investigation was unable to identify the cause for the reported event. (b)(4).

 
Manufacturer Narrative

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

 
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Brand Name"370, BIO-CAL"
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer (Section G)
MEDTRONIC STRUCTURAL HEART
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key5163205
MDR Text Key28806698
Report Number2184009-2015-00116
Device Sequence Number1
Product Code DWJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK894980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number95161-000
Device Catalogue Number95161-000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/14/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/20/2015 Patient Sequence Number: 1
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