MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-28

Device Problem Inaccurate Delivery (2339)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer reports the "original product was not kept.Samples may not be the lot numbers that were used on the patient." hudson aquapak 700 device captured in companion report mdr# 1417411-2018-00008.A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device, or a picture of the alleged defect, was not provided at the time of this report.However, samples were taken from current production.Visual and functional testing showed no issues or discrepancies than can lead to the alleged condition reported by the customer.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The dhr shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed.It is necessary to have the device sample in order to perform a proper and thorough investigation.If the device becomes available this report will be updated with the investigation results.

Event Description

Customer complaint alleges " the hudson rci and aquapak nebulizer failed to produce enough humidity and resulted in thickened secretions.This led to respiratory and cardiac arrest." "the patient was found to be respiratory distress with marked increased work of breathing via their tracheostomy.Breath sounds were coarse throughout and the patient was suctioned several times for very thick, tenacious secretions.The tracheostomy tube became occluded and could not be cleared resulting in a respiratory and eventually a cardiac arrest.A code blue was called, the plugged tracheostomy tube's inner cannula was exchanged, and the patient's respirations returned." it was reported the patient fully recovered.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample was in the original packaging, unopened.No signs of use were identified.Functional testing was performed and no issues were encountered.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.

Event Description

Customer complaint alleges " the hudson rci and aquapak nebulizer failed to produce enough humidity and resulted in thickened secretions.This led to respiratory and cardiac arrest." "the patient was found to be respiratory distress with marked increased work of breathing via their tracheostomy.Breath sounds were coarse throughout and the patient was suctioned several times for very thick, tenacious secretions.The tracheostomy tube became occluded and could not be cleared resulting in a respiratory and eventually a cardiac arrest.A code blue was called, the plugged tracheostomy tube's inner cannula was exchanged, and the patient's respirations returned." it was reported the patient fully recovered.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7209084
• MDR Text Key: 97867388
• Report Number: 3004365956-2018-00026
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-28
• Device Lot Number: 74M1601003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HUDSON AQUAPAK 700
• Patient Outcome(s): Life Threatening; Required Intervention