MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. HX2 TEMPERATURE MANAGEMENT SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS.

Model Number	809810
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Abscess (1690); Death (1802); Pseudoaneurysm (2605)
Date of Event	11/24/2014
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).This information was received by mail on 05-jan-2016 via a voluntary event report (mw5058640) from the fda.This complaint is related to mdr #1828100-2016-00032, mdr #1828100-2016-00033, and mdr #1828100-2016-00035.Per follow-up with the perfusionist (ccp) on (b)(6) 2016: in regards to all of our heater cooler units, we follow the manufacturer¿s recommendations for cleaning.We clean the units weekly with cip-100, our night staff check the chlorine levels daily and add chlorine if necessary to obtain 3-5 parts per million (ppm).All of our preventive maintenance (pms) are handled and scheduled by the manufacturer.
Event or Problem Description
It was reported that the patient developed mycotic aortic arch pseudoaneurysm with mycobacterium abscessus two and a half years after orthotopic heart transplantation and cardiopulmonary bypass (cpb) procedure, requiring the use of the device.The device was not changed out.The surgical procedure was completed successfully.Per the clinical review on 11-jan-2016: manufacturer clinical services staff spoke with the user facility physicians (mds) of the infectious disease section.Our conversation was in regards to the medwatch reports filed by the hospital in reference to the heater cool unit.This patient was diagnosed with a mycobacterium abscessus infection and aortic arch pseudoaneurysm after a heart transplant.The transplant occured on (b)(6) 2012 and the infection was diagnosed on (b)(6) 2014.The patient later expired (date is unknown).According to both mds, there is no connection or association between the heater cooler unit and the patient infection.The hospital was mandated by the state of (b)(6) to retrospectively look back the previous four years for patients that developed mycobacterium infections post cardiothoracic surgery where cpb was used and a heater cooler unit was used during the procedure.This mandate followed the food and drug administration (fda) and center of disease control (cdc) safety communications (in regards to mycobacterium infections associated with heater-coolers) in (b)(6) 2015.According to the mds, they would not have filed the medwatch report if this mandate was not in place, because there was no medical or laboratory data to associate the use of the heater cooler unit with these infections.This heater cooler unit has been used and continues to be used at the hospital.According to both mds, there is mycobacteria in the philadelphia and delaware valley water system and they theorize this was the likely cause of infection in these post-transplant and immunosuppressed patients.There was no delay in the procedure and no blood loss associated with the use of the heater cooler unit.The procedure was completed as scheduled and nothing was changed out during the procedure.
Additional Manufacturer Narrative
The reported complaint was not verifiable.No product is being returned for review.The customer stated there was no product deficiency.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a follow-up emdr will be filed accordingly.

• Brand Name: HX2 TEMPERATURE MANAGEMENT SYSTEM
• Common Device Name: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS.
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 5392980
• Report Number: 1828100-2016-00034
• Device Sequence Number: 377120
• Product Code: DWC
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Followup
• Report Date (Section B): 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 809810
• Device Catalogue Number: 809810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2016
• Supplement Report FDA Received Date: 02/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization