Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Acc

FDA device recall Z-1562-2023 · posted 2023-05-04 · Open, Classified

Recall details

Recalling firm

Inpeco S.A.

Reason for recall

Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B. Inpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.

Action taken

Impeco issued Urgent: Medical Device Correction Letter for affected product: Flexlab/Accelerator a3600/Aptio Automation on 3/10/23 to US Distributors and Direct End Users via email. Letter states reason for recall, health risk and action to take: The scenario occurs in the case of a divert malfunction .. To avoid the occurrence of the described issue lnpeco recommends to visually check every day the gates at the buffer lane entry of the impacted modules (refer to Image l.a and Image l.b) to verify that: there are no obstructions that prevent the correct activation and movement of the divert; the divert looks to be intact, refer to Image 2.a and Image 2.b; the position of the divert is aligned to the profiles when it is diverting a tube, refer to Image 3.a and Image 3.b; tubes that need to be routed by the module are diverted fluidly, without any missing or partial block of the carrier. If the visual check is not passed, contact your local technical support for assistance before using the Automation System impacted modules to process samples. Your service provider will contact you to schedule the firmware upgrade. Until the service visit please maintain awareness on this notice and apply the actions recommended above. Please transfer this notice to whom it might concern. Please complete and return the "Customer Letter Receipt Confirmation and Implementation Check" form attached to this letter within 30 days directly to the email address specified in the email communication. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-maii:Eva.Balzarotti@inpeco.com Phone: (+41) 91 9118 224

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CEM

Quantity affected

US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).

Distribution

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE

Date initiated

2023-03-10

Date posted

2023-05-04

Location

Lugano, Switzerland

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