MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WATER, CONCHA, 1650ML, STD COLMN, RT ANG

Catalog Number HUD38560

Device Problem Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/19/2021

Event Type  Death  

Manufacturer Narrative

It was reported that leakage of the concha column was identified where the top cap and ports separated from the device after four (4) days of use.The leakage was identified when a ventilator alarm for low volume went off.The patient as reportedly on a ventilator due to covid-19.When the leakage was reportedly noticed, the patient was manually bagged while the concha column was replaced.The patient then reportedly coded twice and a pulse was not regained.The cause of death was not disclosed by the reporting facility.A sample was returned and evaluated.Visual inspection of the returned sample identified that an o-ring was not present between the top cap and the column's canister.Small debris from what could be the o-ring was identified at one spot on the canister and also on the inside top surface of the top cap.Although trace particles were noticed on the top cap and canister, the o-ring itself was not present during the investigation.It is possible the o-ring was present and separated and lost after the incident.It was also observed that there was glue all the way around both the top cap and the canister where the glue and o-ring should be at the cap/canister connection point as expected.It was also observed that the tape at the top cap/canister was still in once piece and adhered to the canister.None of the tape was noticed on the top cap although there is what seems to be adhesive residue from the tape on the cap where it was once adhered.The writing on the tape was smeared in a circular pattern, which is unusual and may be the result of friction between the tape and the heater as the canister was turned.This may be due to circuit adjustment with patient reposition.However, the smearing would have required a greater degree of force than turning alone which suggests the column was being pulled with undue force.The neptune heater was not returned to examine the inside surface the column would have been in contact with.It was also observed that there is contamination of some sort on the inside of the column/wicking paper and down the outside and bottom surfaces consistent with possible nebulized medications.It was also observed that there seemed to be a small crack on the inside surface on the top cap where the short level sensing tube is bonded to the top cap.This crack is not on the outside surface of the top cap suggesting it would have not resulted in a leak or contributed to the canister separation.These are most likely due to molding flow lines made visible during bonding.As a result of this investigation, the reported problem/issue was confirmed as the top cap was separated as reported.There was not enough evidence to determine the root cause definitively, however, undue force may have contributed.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a leakage of the concha column was identified.

• Type of Device: WATER, CONCHA, 1650ML, STD COLMN, RT ANG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 12573925
• MDR Text Key: 274688695
• Report Number: 1417592-2021-00185
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HUD38560
• Device Lot Number: 74F1902639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death