MAUDE Adverse Event Report: ABBOTT LABORATORIES DEGASSER INSTALLATION KIT

Catalog Number A-35016140-01

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation into the issues found that diffusion and bi-directional flow caused by a naturally changing delta pressure across the degasser vacuum tubing may allow for waste to enter the shell (vacuum) side of the degasser.Cracks on the degasser fitting that can cause a vacuum leak was found to be due to a cracked fitting on the 3m degasser membrane unit.Additionally, cracks of the water inlet/outlet ports on the degasser housing have been found to cause water to leak out of the degasser housing, into the enclosure and gravity drained through the drain tubing to the space below & outside of the instrument.A product recall letter was sent to all worldwide alinity i customers who have received the degasser installation kit (part number a-35016140-01).The letter informs the customer of the issues with the alinity i degasser installation kit (pn a-35016140-01) and that their abbott representative will contact them to schedule a deinstallation of the alinity i degasser installation kit, and return their instrument to its previous configuration.

Event Description

Abbott has identified the following issues with the alinity i degasser installation kit (pn a-35016140-01): 1.There is a potential for the backflow of waste effluent to the degasser which may reduce the effectiveness of the degasser to remove dissolved gases in the incoming water line 2.Cracks on the degasser fittings may lead to vacuum errors on the alinity i processing module or water leaks from the degasser unit none of the issues have the potential to impact patient results.The degasser is an optional part and is not necessary for proper instrument operation or testing.In issue 1, by introducing liquids to the outside of the fiber, it would create a condition of wet-out.This condition would prevent the degasser from removing dissolved gasses from the incoming water.This situation would supply the instrument with the same water quality as what was supplied before the degasser was installed; therefore, there is no potential for incorrect results.There is no potential for chemical, biohazard, or physical hazards as there are no leaking fluids and a user is not expected to come into contact with any fluids.There is no potential for electrical hazard as there are no exposed electrical components with which a user could come into contact.In issue 2, a water leak from the degasser unit has the potential to impact user safety as this water leak near the alinity i processing module can lead to a slip/fall.There have been no incidences of slip/falls reported.

• Brand Name: DEGASSER INSTALLATION KIT
• Type of Device: DEGASSER INSTALLATION KIT
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 11123350
• MDR Text Key: 225291039
• Report Number: 3016438761-2020-00341
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A-35016140-01
• Device Lot Number: ALL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESS MODULE, LIST 03R65-01