MAUDE Adverse Event Report: ATOS MEDICAL AB PROTRACH XTRACARE BLUE; HEAT AND MOISTURE CONDENSER (ARTIFICIAL NOSE).

Catalog Number 7768

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 12/20/2014

Event Type  malfunction  

Event Description

(b)(6) 2014 at 18:30, the patient´s hme was exchanged by his mother and he received a protrach xtracare.At approximately 03:00 his mother went to check on him as usual.She then noticed that the patient was breathing very roughly and irregularly.The oximeter showed a saturation of 78%.She removed immediately the protrach xtracare and the o2 saturation rose again above 90%.The patient¿s mother states that the filter was not full of mucus but completely normal and dry, but it was not possible to exhale through it.Later information added that the patient was not capable of removing the device himself and was only monitored sporadically.The oximeter alarm limit was set to 85% but the alarm was apparently not noticed.

Manufacturer Narrative

Visual inspection: upon arrival the product was wet in the bag, and the white electrostatic filter had a brownish yellow color.The product was taken out of the bag and inspected: the product components were intact.The plastic ribs inside were without deformation indicating that the product has been attached to the trach tube in a normal way.The filter had a brownish yellow color, both outside and inside the product.This indicates that the filter was soaked with mucus.Flow resistance measurement: at a flow rate of 10 l/min the resistance was 270 pa.At a flow rate of 30 l/min the resistance was over 1000 pa and bubbles/lather raised from the product.(normal values for a new protrach xtracare are at 10 l/min=20 pa and 30 l/min =70 pa.During use and fully moisturized these values raise to approximately 40 pa and 140 pa at 30 l.) conclusion: it is obvious that the product was clogged by mucus, the wet and brownish yellow color of the filter together with high flow resistance through the product indicates that filter was soaked and clogged by mucus.No product non-conformities were identified.According to the protrach xtracare ifu it is clear that this patient is contraindicated for using this device: 1.2 contraindications: protrach xtracare is contraindicated for patients who are unable to handle or remove the device themselves when needed, and who are not under constant supervision of a clinician or trained caregiver.Additionally it is clearly outlined when the hme must be replaced: 2.Instruction for use: the device is for single use and must be replaced at least every 24c hours, or more often as needed (e.G.If clogged by mucus or wet).

• Brand Name: PROTRACH XTRACARE BLUE
• Type of Device: HEAT AND MOISTURE CONDENSER (ARTIFICIAL NOSE).
• Manufacturer (Section D): ATOS MEDICAL AB; po box 183; kraftgatan 8; horby, SE-2 42 2; SW SE-242 22
• Manufacturer (Section G): ATOS MEDICAL AB; po box 183; kraftgatan 8; horby, SE-2 42 2; SW SE-242 22
• Manufacturer Contact: ferenc dahner ; po-box 183; horby, SE-24-2 22 ; SW SE-242 22 ; 415 19800
• MDR Report Key: 4425117
• MDR Text Key: 5167865
• Report Number: 8032044-2015-00002
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/16/2015

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: Patient Family Member or Friend
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 7768
• Device Lot Number: 1409133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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
• Patient Outcome(s): Other