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

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.

• 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): 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 Key: 5163205
• MDR Text Key: 28806698
• Report Number: 2184009-2015-00116
• 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: 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 Received: 10/20/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 10/14/2006
• 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