MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID-FLO HME; CONDENSER, HEAT AND MOISTURE (

Catalog Number 19912

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: (ambu).(b)(4).

Event Description

Customer reported a substance was found on the device during use and tested positive for growth of aspergillosis.The customer reported the source of the growth had not been determined at the time of this report and that the ventilator has also been cultured.The patient was not cultured for aspergillosis and did not require any medical intervention or treatment.The patient was reported to be off of the ventilator.

Manufacturer Narrative

Continuation of d11: (ambu) (b)(6).The sample was not returned; however, the customer provided photos for evaluation.In the photos, mold could be seen on the product filter.It was reported that the patient was on the product for 12 hours before the substance was discovered.The customer also reports the product tested positive for aspergillosis.From literature review, aspergillosis is an infection caused by aspergillus, a common mold (a type of fungus) that lives indoors and outdoors.Most people breath in aspergillus spores every day without getting sick; however, people with weakened immune systems or lung diseases are at higher risk of developing health problems due to aspergillus.The types of health problems caused by aspergillus include allergic reactions, lung infections, and infections in other organs.The mold found on the filter may be caused by the accumulation of secretions from the patient or contamination after usage.The customer reports that no abnormality was found before usage.In the current manufacturing procedure, a visual inspection is conducted during the assembly process and 100% drop testing is conducted at the assembly area; thus, any defects would be detected prior to release from the manufacturing facility.

Event Description

Customer reported a substance was found on the device during use and tested positive for growth of aspergillosis.The customer reported the source of the growth had not been determined at the time of this report and that the ventilator has also been cultured.The patient was not cultured for aspergillosis and did not require any medical intervention or treatment.The patient was reported to be off of the ventilator.

• Brand Name: HUDSON HUMID-FLO HME
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9682794
• MDR Text Key: 183755296
• Report Number: 8040412-2020-00039
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 19912
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRAGER VENTILATORCIRCUIT - MANUFACTURED BY (B)(4).; DRAGER VENTILATORCIRCUIT - MANUFACTURED BY (B)(4).