MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MASS SPECTROMETER; VITEK® MS

Model Number 410895

Device Problems Grounding Malfunction (1271); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomérieux to report the tray jammed into the left side of the vitek® ms load door, breaking the stage ground strap.The stage ground strap is a safety device to protect users from potential electrical shock.The local field service engineer (fse) visited the customer site to perform appropriate instrument repair and confirmation of proper operation.There is no indication or report from the hospital laboratory to biomérieux that the damaged ground strap led to any adverse impact to the user or to any patient's state of health.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

If remedial action initiated, check type - repair should not be checked for supplement 1, submitted on 09/25/2017.

Manufacturer Narrative

Customers reported to biomérieux that the stage ground strip (reference (b)(4)) was broke/missing on the vitek® ms instrument.An investigation was performed.Vitek® ms instrument configuration (.Cfg) files were returned to and reviewed by kratos (vitek® ms instrument manufacturer).There were no irregularities.The files are identical to the factory.Cfg file, for the five (5) files that were received and reviewed.A review of photos of the broke/missing stage ground strip and door, shows that the ground strip appears to be broken by binding and not cyclic fatigue, due to the breakage and abrupt bend in the stage ground strip.It appears it was pinched and this caused the breakage.Kratos conclusion is most likely a handling issue with the stage, either physically or via software stage move commands sent via putty (instrument serial communication application).The stage can also behave strangely and drive to the incorrect place, but this is usually accompanied by the configuration and stage location corrupting which would have alerted us to this cause.Kratos completed testing to confirm that other safety mitigations are correctly implemented on vitek® ms.Kratos confirmed there was no manufacturing issue or design change on the stage ground strip since 2011.There was only a re-draw of the same ground strip with a new design software in 2013.There was no cyclic metal fatigue as confirmed through kratos durability testing for the new door design.There was no loss or corrupt configuration files when reviewed by kratos.The dsp control board was replaced but it was not returned to check if it was defective.The above probable root causes could not be confirmed from the information and data received.The stage ground strip is a safety device located on the vitek ms® to prevent the user from electrical shock.When the instrument door is opened, the stage ground strip ensures contact between the instrument stage, the supporting the samples slides holder and the instrument ground.The risk of electrical shock is mentioned in the vitek® ms risk analysis, stated the severity is critical (per hazard definition), and the initial probability is occasional (possible for a relative few occurrences over the life of the product.) the final probability after mitigation by design is improbable (assumed not to occur or cannot be distinguished from zero).Kratos assessed the occurrence of the risk in case the stage ground strip as improbable (probability unchanged due to the multiple other failures which would be required to occur at exactly the same time).Kratos provided more details regarding the other mitigations in place to prevent the user or the field service engineer (fse) from electrical shock.Dc power supply is turned off: the software switches the instrument to standby.The sample plate is positioned behind the door opening and the sac is vented over a set period.Vacuum interlock: once the vacuum is close to atmospheric pressure then the hv interlock operates to shut off the hv voltages.Also when the vacuum is at atmospheric pressure then this would in effect provide a short circuit to the hv power supply and the power supply's in built protection circuits would then switch off the supply to protect the power supply (in practice this would happen well before atmospheric pressure is reached).So this a backup security for the vacuum interlock on the hv supply being off through vacuum pressure change.Grounding strip: as the plate carrier drives through the door then the contact spring makes a final physical short circuit and again the power supply's built in protection circuits would then switch off the supply to protect the power supply.Also, when the sample plate is then driven though the door, pushing it open, this contact ensures that a physical short circuit is made for any voltage on the sample plate.Again the power supply's built in protection circuits would then switch off the supply to protect the power supply.This represents a backup security of grounding strip to ensure hv is off (at zero volts) through physical grounding.Kratos stated that, although the risk of high voltage (hv) electrical shock is improbable when ground strip is faulty (ref impact analysis), the broken ground strip may lead, due to broken metal sharp edges in the vacuum, to hv breakdown electrical arcs in the instrument.Electrical arcs may lead to spectra bad quality, which will lead to no identification result.Additional maintenance of the instrument would then be needed due to damage of some components with electrical arcs (burnt marks to be cleaned for example).This risk on instrument damage will be added in a next revision of the kratos instrument service manual as follow : "possibility of hv electrical shock, if the ground strip is faulty.The vitek® ms instrument must not be used if the ground strip is not functioning correctly." changed to "possibility of hv electrical shock and hv breakdown that can cause damage to the instrument, if the ground strip is faulty.The vitek® ms instrument must not be used if the ground strip is not functioning correctly." a change request has been created for this update at biomérieux as well as kratos.The fse installed new replacement part on the vitek® ms instrument during preventative maintenance (pm).Records confirmed that the instrument was maintained and pm was completed according to procedures.Biomérieux will continue to monitor this issue for significant trends for one year and collect any relative information for potential events.

• Brand Name: VITEK® MASS SPECTROMETER
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6391841
• MDR Text Key: 69575471
• Report Number: 3002769706-2017-00044
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1