MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 700 SW,760 ML; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 037-00C

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 rci nebulizer adaptor 028 captured in mdr 3004365956-2018-00026.A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record review shows no issues that may have contributed to any quality issues reported.No sample available from the customer to investigate.Complaint not confirmed.Root cause unknown.Teleflex will continue to monitor feedback from the customers on issues related to failure to produce enough humidity on water bottle products.If the device sample becomes available at a later date, this report will be updated with the evaluation 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).A 760 ml water bottle product 037-00c lot 020170 was received in the original packaging for evaluation.Visual inspection of the sample did not show any defects.A nebulizer adaptor (b)(4) was threaded onto the water bottle.The penetrating pin was inserted into the puncture port and the adaptor was threaded onto a flow meter.The flow meter was set at 5 lpm and then 10 lpm.Liquid flowed through the return tube and the water bottle functioned as expected.Complaint for failed to produce humidity is not confirmed.No issues were found with the returned sample.

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 AQUAPAK 700 SW,760 ML
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7209007
• MDR Text Key: 97860906
• Report Number: 1417411-2018-00008
• 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 Expiration Date: 03/03/2021
• Device Catalogue Number: 037-00C
• Device Lot Number: 020170
• 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: 03/08/2018
• Supplement Dates FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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: HUSDON RCI NEBULIZER ADAPTOR 028
• Patient Outcome(s): Life Threatening; Required Intervention