MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY

Model Number 101/860/080CZ

Device Problems Device Alarm System (1012); Pressure Problem (3012)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Information received a smith medical tracheostomy|pvc - portex tubes bluselect malfunctioned.During the use of the product, a high-pressure warning alarm kept sounding.It persisted even after the customer performed a suction or adjusted the cuff air pressure.Every time the alarm went off, the tidal wave lowered accordingly.The spo2 value did not go down, but the respiratory conditions of the patient got worse.So the customer replaced the product with a non-smiths' one.After that, the situation got better.No patient injury.

Manufacturer Narrative

Other, other text: one used decontaminated sample 10009163-004 8mm deht blu suctionaid sub-assy 1/ea was received in plastic bag without its original packaging.High pressure warning of ventilator might be enabled because of increased or thicker mucus or other secretions blocking the airway.It can happen when suctioning of patient airway is not properly done.Under visual inspection of returned sample we noticed that suction connector is not present on suction line which might cause not effective suctioning.Affected suction line is manufactured in smiths medical tijuana and is inspected as per pwi-10008350 rev.102.Bonding of connector with suction line is functionally checked as per chapter 4 bond of tube to connector of suction line with frequency 16 samples at the start of the shift and every hour during the shift.Each tracheostomy tube (including suction line with connector) is also visually inspected during tracheostomy tube assembly process which is done in smiths medical czech republic as per pwi-10011068, pwi-10011069, pwi-10011070 and pwi-10011098.It is highly improbable that suction line without connector would pass this inspection.Based on results of this investigation reported issue happened the most probably because of not effective suctioning during use which was caused as result of suction connector vs suction line separation.Root cause of this separation remains unknown.No trend of similar customer complaints was identified.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10457016
• MDR Text Key: 204461353
• Report Number: 3012307300-2020-08523
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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?: No
• Device Operator: No Information
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1