MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information for section d4 and h4: d4 serial #: (b)(6).D4 unique identified (udi)# (b)(4).H4 device mfg date: 12/13/2017.D4 serial #: (b)(6).D4 unique identified (udi)# (b)(4).H4 device mfg date: 08/03/2018.D4 serial #: (b)(6).D4 unique identified (udi)# (b)(4).H4 device mfg date: 10/02/2018.D4 serial #: (b)(6).D4 unique identified (udi)# (b)(4).H4 device mfg date: 10/25/2018.D4 serial #: (b)(6).D4 unique identified (udi)# (b)(4).H4 device mfg date: 11/12/2019.D4 serial #: (b)(6).D4 unique identified (udi)# (b)(4).H4 device mfg date: 11/24/2021.D4 serial #: (b)(6).D4 unique identified (udi)# (b)(4).H4 device mfg date: 06/24/2022.The investigation into this issue confirmed there is no failure to meet design inputs or product requirements.The use of an external waste pump not intended for use with the alinity s system does not impact the functionality of the instrument.The cause of the issue is due to human error as the service personnel did not check the pump part number in the global product part master (gppm) database before installing to ensure the part is linked to the alinity s system.A product correction letter was issued on 08feb2024 to the alinity s system customers who have the abbott external waste pump connected to their alinity s system.The product correction letter notifies them of the issue, potential impact to user safety, and provides the customer of liquid waste specifications, which will be included in a future version of the alinity s system operations manual.Additionally, the product correction letter informs the customer their abbott representative will contact them to discuss waste drainage options within the laboratory and schedule a disconnection of the external waste pump from the waste line of the alinity s system.The letter also contains the necessary actions for the customer to take if foaming/bubbling/leaking occur, which includes: ensuring the floor is dry and clean under and around the alinity s system(s) and the external waste pump(s); use good laboratory techniques and always wear personal protective equipment (ppe) when operating the alinity s system(s); and refer to hazards section in the alinity s system operations manual for spill cleanup should waste escape onto the floor.
Event or Problem Description
Abbott has identified an issue where an abbott external waste pump, not intended for use with the alinity s system, was installed on seven distributed alinity s systems.The issue was initially identified via troubleshooting of a high pressure message code on a distributed alinity s system.An abbott external waste pump was installed to resolve the issue.During documentation of the issue, it was identified that the external waste pump is not intended for use with the alinity s system.A field data review concluded a total of seven external and eight internal analyzers with an abbott external waste pump connected.There is a potential for leakage or foaming at the external waste pump(s) which could result in liquid escaping the pump onto the floor; thus, the potential exists for a physical/operator injury (slip / fall) and/or biohazard exposure due to liquid waste on the floor around the external waste pump(s).There have been no occurrences of operator injury or biohazard exposure as a result of this issue.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18764259
• Report Number: 1628664-2024-00004
• Device Sequence Number: 19930245
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1628664-02/14/2024-003-C
• Patient Sequence Number: 1
• Patient Sex: Unknown