MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT LINER CANNSTR SUCT 1500CC DISP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651-515

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The component lot number was not available; therefore, the device history record could not be reviewed.The complaint was reviewed by engineering, quality, and production.The process risk file was reviewed, and it was confirmed that this type of defect has control of visual inspection at a level specified in our sampling plan.No sample or photos were available.The investigation also included internal lab testing conducted on (b)(6) 2020, which resulted in these comments: the pressure-drop across the ppv filter ranges from 3.0 to 3.5 inches of mercury ¿ this is approximately 75-80mm of mercury.Correspondence from the customer indicated they do not know what the vacuum level was set at, but on the regulator, low suction is 0-50 mm.If a crd 1.5l (or any size for that matter) was not properly assembled allowing air to leak in, that amount of pressure drop would likely cause the canister not to deliver clinically effective gastric suction at approximately 50mm of mercury.Additional research performed at the site: typical gastric suction is performed at low vacuum levels up to 80mm of mercury; if there was any air leaking into the canister it would not deliver clinical suction.Vacuum levels below 150mm hg suction are categorized as low vacuum in the applicable iso standard (10079-3).Medi-vac canisters are rated for all suction ranges; however, any leak caused by improper set-up would prevent the canister from providing suction at the levels used by the customer.Based on the customer inquiry, it is not understood how they could have verified the suction after set-up before leaving the patient because they stated the filter was not wet and they identified the failure mode to be a defective filter ¿ in this was the case the suction would have never worked.Correspondence from the customer indicated ¿the canister was connected to wall suction, above the level of the head of bed, which was elevated¿.Having the canister above the bed at this low vacuum level is a challenge for any suction system.A second internal lab test was conducted.It was determined that at the height of 19¿ or more measured vertically from the bottom of the canister to the suction site at 50mm mercury of vacuum the canister could not suction fluid because the weight of the fluid in the tube would equal the suction force.The assignable cause was unable to be determined.The suction failure is suspected to have been caused by user error such as improper assembly, the canister located too high above the suction site, or too low of a vacuum level for the height of the canister.No further actions are planned at this time.

Event Description

Based on the report from the customer reportedly the ppv filter is preventing suction from performing properly.When the ppv filter was removed from the canister lid, there were no issues with suction.There was no liquid in the canister at the time of suction issue, so it was not a case where liquid touched the filter engaging the suction to cease.The issue was discovered when patient was found reportedly covered in gastric contents, and suction canister was empty.Per the customer, there was no injury, the patient is stable, they did not need any medical interventions, just to be cleaned up.

• Brand Name: LINER CANNSTR SUCT 1500CC DISP
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer (Section G): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 10438374
• MDR Text Key: 205141150
• Report Number: 1423537-2020-00498
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00630140152651
• UDI-Public: 00630140152651
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 65651-515
• Device Catalogue Number: 65651-515
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other