MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-GARD HEPA,SMALL STRAIGHT

Catalog Number 28062

Device Problem Complete Blockage (1094)

Patient Problems Extubate (2402); Low Oxygen Saturation (2477)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No oxygen saturation numerical value was reported.The device involved has not been received for evaluation at the time of this report.The investigation is still in progress.

Event Description

Customer complaint alleges that "the patient had a surgery under general anesthesia.At the end of the intervention, the ventilatory pressures increased suddenly, so the ventilation became impossible".Clinical consequence reported: the patient desaturated 30% during 1 {one} minute.There was a lack of "tital volumne," no capnography.A bronchospasm was considered.The patient was extubated after surgery and the patient is fine now.Interventions reported: deeping of anesthesia and ventolin did not resolve the issue.The intubation was changed but with no success.The filter was then replaced which resulted in the return of proper ventilation of the patient and quick re-saturation.Customer concluded "overall, the increase of the pressures was induced by the completely clogged antibacterial filter.The occlusion is due because of the moisture between the patient and the filter.".

Event Description

Customer complaint alleges that "the patient had a surgery under general anesthesia.At the end of the intervention the ventilatory pressures increased suddenly so the ventilation became impossible".Clinical consequence reported: the patient desaturated 30% during 1 {one} minute.There was a lack of tital volumne, no capnography.A bronchospasm was considered.The patient was extubated after surgery and the patient is fine now.Interventions reported: deeping of anesthesia and ventolin did not resolve the issue.The intubation was changed but with no success.The filter was then replaced which resulted in the return of proper ventilation of the patient and quick re-saturation.Customer concluded "overall, the increase of the pressures was induced by the completely clogged antibacterial filter.The occlusion is due because of the moisture between the patient and the filter.".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the filter was blocked.The device also failed the drop test.This happens due to the accumulation of condensation or secretions during use.The ifu for this product states to position the patient side connector of the humid-vent hepa higher than the et tube connector to avoid accumulation of secretions.It also states to replace the unit immediately if there is increasing resistance, if it is soiled with secretions, or otherwise obstructed.The recommended tidal volume is 300-1200, do not use on lower tidal volumes.At the manufacturing site, 100% drop testing is conducted on the product and the device will be rejected if there are any blockages.Based on the investigation performed, the reported complaint was confirmed.It was found that the product was assembled correctly.The reported failure could happen due to the accumulation of condensation or secretions during usage, although an exact root cause could not be identified.

• Brand Name: HUDSON ISO-GARD HEPA,SMALL STRAIGHT
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 7794150
• MDR Text Key: 117833379
• Report Number: 8040412-2018-00213
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 28062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENTILATOR; VENTILATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 90