MAUDE Adverse Event Report: AVANOS MEDICAL INC. TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 227

Device Problems Suction Problem (2170); Obstruction of Flow (2423)

Patient Problems Death (1802); Respiratory Distress (2045)

Event Date 04/15/2020

Event Type  Death  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.Photos of the device were provided by the user facility.All information reasonably known as of 01 jul 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).

Event Description

Avanos medical inc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the fifth of five reports.Refer to 8030647-2020-00038 for the first report.Refer to 8030647-2020-00039 for the second report.Refer to 8030647-2020-00040 for the third report.Refer to 8030647-2020-00041 for the fourth report.It was reported that the "et [endotracheal] tube [ett] clogged with tenacious secretions." additional information received 16-jun-2020 indicated the patient was admitted and intubated on (b)(6) 2020.On (b)(6) 2020 patient had "increased driving pressures, not returned to his vt [tidal volume], unable to pass an inline suction catheter through ett.Ventilator removed, patient bagged with 100% o2 [oxygen].Straight suction catheter passed with difficulty through ett.Moderate amount of thick bloody plugs removed.Patient placed back on ventilator without difficulty." the user facility stated "you can hear the secretions 'rattling' even though you have just or in the process of suctioning.In some instances they don't get anything out but can hear it.Sometimes they will remove the patient from the vent and straight cath them to get the secretions.In some instances when we are not getting the secretions the xray is not improving and o2 [oxygen] requirements not improving they will bronch [bronchoscopy] the patients and will get tons of secretions with plugs." additional information received 17-jun-2020 indicated the patient's cause of death was "cardiac arrest.He had other comorbidities the [that] attributed to his demise.The incident with the ett happened 2 days prior and the therapist was able to disconnect the vent and straight cath the patient to remove the secretions.".

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Photos of the device were provided by the user facility.However, no root cause was identified.All information reasonably known as of 16 sep 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint: (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10217916
• MDR Text Key: 197127513
• Report Number: 8030647-2020-00042
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038938394
• UDI-Public: 00609038938394
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 227
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 106