MAUDE Adverse Event Report: SORIN HEATER COOLER 3T 120 VOLT

Device Problems Labelling, Instructions for Use or Training Problem (1318); Inadequate Instructions for Healthcare Professional (1319); Device Maintenance Issue (1379); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2015

Event Type  malfunction  

Event Description

Health system suspected/identified the following problems with product: due to an unusual cluster of non-tuberculosis mycobacterium seen in pts post cardiothoracic surgery and recent reports from europe indicating that aerosolization of this bacteria may be emitted from the sorin heater cooler unit, our facility notified (b)(6) of our concern.At the request of the state, (b)(6) sent a field team to our facility to conduct an investigation.The results of the investigation are pending.There are concerns on the maintenance of this machine: manufacturer instructions are inconsistent between user manual, field safety notice, faq, "quick start" guide and instructional video.The method of updating disinfection requirements have not been consistently distributed.The sales representative's verbal info is not always consistent with the written recommendations.The company's representative sent to place a new machine in production did not follow their established guidelines for disinfection.There is concern if the multiple disinfection procedure changes will mitigate any potential biofilm growth.Documentation or studies have not been provided.The steps for meeting the new recommended disinfection protocols are confusing and complex.Currently, there is not one document that has all recommendations; each of the documents listed in 2a of this section must be independently reviewed and considered.

• Brand Name: HEATER COOLER 3T 120 VOLT
• Type of Device: HEATER COOLER 3T 120 VOLT
• Manufacturer (Section D): SORIN; munich ; GM
• MDR Report Key: 5104593
• MDR Text Key: 27020215
• Report Number: MW5056456
• Device Sequence Number: 2
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/18/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other