MAUDE Adverse Event Report: VAPOTHERM PRECISION FLOW; VAPOTHERM PRECISION FLOW

Model Number PF-UNIT

Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919); Moisture or Humidity Problem (2986)

Patient Problems Aspiration/Inhalation (1725); Death (1802)

Event Date 01/28/2018

Event Type  Death  

Manufacturer Narrative

The event as reported by the family member represents a failure to follow the vapotherm instructions for use as non-vapotherm tubing was used.Reached out to customer facility where event occurred, and they were unable to locate any records of an event similar to the one reported.

Event Description

Vapotherm's compliance hot-line was used by a patients family member to report an event that occurred in (b)(6) 2018.The report describes misuse of vapotherm's device resulting in the death of the patient.Additional information is not available at this time due to confidentiality controls on the reporting tool.The family members report is as follows."hello, i need to report that the wrongful use of the vapotherm unit caused my granddaughters death.(b)(6) 2018 at (b)(6) hospital in (b)(6) under the care of dr.(b)(6).The vapotherm was setup with the wrong tubing.Correct tubing could not be found to replace it with.The tubing used to deliver her breathing treatment was too short.My granddaughter had to lay perfectly flat and still or liquid would go in her nose.The entire time she was on the vapotherm the tubing was never removed or changed.The liquid breathing medication did not evaporate properly.After hours of condensation and liquid medication building up a nurse unknowingly picked up the tubing pouring all the liquid into my granddaughters nose and causing a nasal aspiration that she could not overcome.She was 6 months old.I have read the vapotherm warnings against this very thing which makes it even harder to understand how this could happen.".

• Brand Name: PRECISION FLOW
• Type of Device: VAPOTHERM PRECISION FLOW
• Manufacturer (Section D): VAPOTHERM; 100 domain drive; exeter NH 03833
• Manufacturer (Section G): VAPOTHERM; 100 domain drive; exeter NH 03833
• Manufacturer Contact: dennis francoeur ; 100 domain drive; exeter, NH 03833 ; 6036580491
• MDR Report Key: 9362547
• MDR Text Key: 167595727
• Report Number: 3012971441-2019-00001
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 00841737100140
• UDI-Public: 00841737100140
• Combination Product (y/n): N
• PMA/PMN Number: K072845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/24/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: PF-UNIT
• Device Catalogue Number: PF-UNIT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/22/2019
• 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
• Treatment: AEROSOL DELIVERY SYSTEM
• Patient Outcome(s): Death
• Patient Age: 6 MO