MAUDE Adverse Event Report: ABBOTT LABORATORIES DEGASSER INSTALLATION KIT

Catalog Number A-35016140-01

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation into the issues found that 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 two 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

During completion of the removal of the inlet water degassing system on the alinity i processing module, sn (b)(4), a leak was found in the degassing housing.Water was noted to be on the floor from overflow in the degasser.There was no reported impact to patient management or user safety.

• 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: 11176887
• MDR Text Key: 227003915
• Report Number: 3016438761-2021-00014
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/15/2021

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: A-35016140-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/15/2021
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI01438