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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR CIRCUIT,UNIVERSAL NEONATAL W; CIRCUIT, BREATHING (W CONNECTO
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TELEFLEX MEDICAL HUDSON VENTILATOR CIRCUIT,UNIVERSAL NEONATAL W; CIRCUIT, BREATHING (W CONNECTO Back to Search Results
Catalog Number 780-10
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
Customer reported the circuit was not working.Per customer "patient in ventilatory failure, requires tracheal gold intubation, when connecting to the mechanical fan does not start ventilation, it is tried with three more fans and it is not possible to start mechanical ventilation immediately.The case is reported to medical teams and the engineer in charge ensures that the damage is caused by the neonatal mechanical ventilation circuit.".No patient harm reported.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one a full 780-10 ventilator tubing set for investigation.Upon receiving the circuit, it was visually examined for any signs of misuse/abuse/damage.No cracks or holes were found.No other obvious defects or anomalies were noted.All port caps were secure and nothing unusual was noted on how the circuit felt.The customer also returned a section of tubing to belonging to the 780-10 set.It appeared as if this tubing had been cut or torn.The leak rate specification is governed by iso 5367:2014, annex e, which specifies neonatal circuit under 60 +- 3 cmh2o of air pressure, cannot exceed a leak rate greater than 30 ml/min.The circuit was hooked up to a leak tester and was leak tested under 60 +/- 3 cmh2o of air pressure.The tubing leaked at a rate of 11 ml/min, which is below the acceptable iso limit of 30 ml/min.For the section of returned tubing , iso 5367:2014 specifies, "leakage from breathing tubes supplied to be cut to length shall not exceed 10 ml/min at (60 3) hpa [(60 3) cmh2o], per meter length of tubing." the section was hooked up to a leak tester and was leak tested under 60 +/- 3 cmh2o of air pressure.The tubing leaked at a rate of 1 ml/min.Since the tubing was measured to be 0.425 meters, the allowed leak rate is 4.25 ml/min.The section of tubing is below the acceptable iso limit.The reported complaint of a circuit not working was unable to be confirmed based upon the sample received.The returned circuit was confirmed to leak at 11 ml/min.This is well below the iso standard of 30 ml/min.Functional testing did not reveal any operational anomalies.
 
Event Description
Customer reported the circuit was not working.Per customer "patient in ventilatory failure, requires tracheal gold intubation, when connecting to the mechanical fan does not start ventilation, it is tried with three more fans and it is not possible to start mechanical ventilation immediately.The case is reported to medical teams and the engineer in charge ensures that the damage is caused by the neonatal mechanical ventilation circuit." no patient harm reported.
 
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Brand Name
HUDSON VENTILATOR CIRCUIT,UNIVERSAL NEONATAL W
Type of Device
CIRCUIT, BREATHING (W CONNECTO
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9220994
MDR Text Key198500067
Report Number3004365956-2019-00291
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number780-10
Device Lot Number74H1802138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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