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

Catalog Number	06P16-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
During installation of the alinity s system, a message was observed indicating the bulk solution drawer was offline, and the instrument transferred to the stopped position.It was observed that there was no power to the board, and there was damage to the board power cable.One of the red cables in the cable bundle was blackened (charred) and separated into two pieces.After cable replacement it started to work normally.No injury to the user was reported.No impact to patient management was reported.
Additional Manufacturer Narrative
The ambassador inspected the analyzer and provided pictures illustrating a cable bundle with frayed sheathing and blackened ends for cables underneath on the cable - bulk solutions icb power.The part was replaced to resolve the customer issue.A review of complaint data did not identify an increase in complaint activity related to the cable - bulk solutions icb power or the alinity s instrument with regard to the complaint issue.Additionally, a review of the instrument service history for the customer's alinity s system identified no additional issues or contributing factors to the current complaint.An evaluation of the returned cable - bulk solutions icb power found that the cable was received with frayed sheathing.Investigation noted that the damage to the cable in the cable - bulk solutions icb power was limited to the cable and did not spread to other parts on the instrument.There is no failure to meet design input and no potential for a biological, chemical, physical, environmental, or electrical hazard for the event.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.The alinity s system service documentation provides adequate information for electrical hazards during operation and maintenance and for the removal, replacement and verification of the cable - bulk solutions icb power.Additionally, the alinity s system operations manual contains adequate information for performing an emergency shutdown on the instrument, regarding electrical hazards and for troubleshooting the observed message code and power interruptions.Based on the investigation, no systemic issue or deficiency was identified for the alinity s system serial (b)(6) or the cable - bulk solutions icb power.
Event or Problem Description
During installation of the alinity s system, a message was observed indicating the bulk solution drawer was offline, and the instrument transferred to the stopped position.It was observed that there was no power to the board, and there was damage to the board power cable.One of the red cables in the cable bundle was blackened (charred) and separated into two pieces.After cable replacement it started to work normally.No injury to the user was reported.No impact to patient management was reported.

• 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: 20938471
• Report Number: 1628664-2024-00007
• Device Sequence Number: 4566792
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: BL125674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CABLE - BULK SOLUTIONS ICB POWER, B-30104601-01, U; CABLE - BULK SOLUTIONS ICB POWER, B-30104601-01, U
• Patient Sex: Unknown