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

Model Number 809810

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 08/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is related to mdr #1828100-2016-00032, mdr #1828100-2016-00033, and mdr #1828100-2016-00034.Per follow-up with the perfusionist (ccp) on 21-jan-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.Per clinical review follow-up for mdr #1828100-2016-00032, mdr #1828100-2016-00033, and mdr #1828100-2016-00034; the physician (md) mentioned there is a fourth medwatch that was sent to the fda.A search of the fda maude data base was performed, no additional voluntary medwatch report was found at this time.(b)(4).

Event Description

It was reported the patient developed a mycobacterium infection after a cardiopulmonary bypass (cpb) procedure, requiring use of the device.No other details regarding the nature of this event were provided.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 after a procedure in which cpb with a cooler-heater was performed.Additional patient information has been requested.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 october 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 (b)(6) water system and they theorize this was the likley cause of infection in these post-transplant and immunosupressed 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.

Manufacturer Narrative

Additional information was received by mail on 08-feb-2016 via a voluntary event report (mw5059336) from the fda.Manufacturer clinical specialist confirmed the attached.Pdf received from the fda matches this complaint record.The reported complaint was not verifiable.No evidence links the lvad surgery to the subsequent infection event.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.

Event Description

Additional information: the device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.The date the patient was diagnosed with the infection was approximately (b)(6) 2015; presented in (b)(6) 2015 with a one month history of subcostal swelling.The patient is alive today.Patient developed mycobacterium abscessus (pericardial) and mycobacterium avium intracellulare (pericardial and abdominal abscess associated with drive line) infection 2.7 years following placement of a heartmate ii left ventricular assist device (lvad) on 2012 as destination therapy for non-ischemic cardiomyopathy.Lvad placement performed with cardiopulmonary bypass using heater cooler (hx2) unit.Event is being reported per the request of (b)(6).No evidence links the lvad surgery to the subsequent infection event.Patient had developed subcostal swelling below right rib cage in 2015 along the lvad drive line site.

• Brand Name: HX2 TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS.
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5392983
• MDR Text Key: 36909544
• Report Number: 1828100-2016-00035
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 809810
• Device Catalogue Number: 809810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening