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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD MAX¿ SYSTEM INSTRUMENT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
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BECTON, DICKINSON & CO. BD MAX¿ SYSTEM INSTRUMENT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS Back to Search Results
Model Number 441916
Device Problem Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported while using a bd max¿ system instrument the lab technician was changing the pcr card when the instrument presented an error and max arm began moving with the door open.The option "emulate parallel port" was selected and the technician deselected the option.No injuries were reported.
 
Event Description
It was reported while using a bd max¿ system instrument the lab technician was changing the pcr card when the instrument presented an error and max arm began moving with the door open.The option "emulate parallel port" was selected and the technician deselected the option.No injuries were reported.
 
Manufacturer Narrative
H.6.Investigation summary: the complaint of "during the test when changing the pcr card.The bdmax.Began to move" was reported against bd max system associated with instrument catalog number 441916, serial number (b)(6).The complaint was flagged as a potential safety concern.The complaint was confirmed by bd service and engineering.An option which is available only to a user with service permissions was enabled which allows the instrument to operate with the door open.The investigation consisted of a review of the service notes pertaining to the incident, the service history of the instrument, and a review of related instrument complaint trending data.The problem was resolved remotely, no parts or materials were replaced or returned.The root cause of the problem is suspected to be related to field service error.No injuries were reported in conjunction with the complaint.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends with associated problems.Investigation conclusion: a customer complaint was received regarding unexpected behavior of a bd max system during a sample run.The customer reported that the robot began to move while the door of the instrument was open.The robot is ordinarily disabled while the door is open to prevent user injury.No injuries were reported in conjunction with the complaint.Technical service assisted the user remotely in adjusting the settings of the instrument to resolve the problem.Field service users of the bd max system software have an option available to disable the door interlock sensor for troubleshooting purposes.This option is not available to a customer with standard user permissions.The service history of the instrument was reviewed.Preventative maintenance was completed approximately a month prior to the incident.The instrument may have been put in service mode at this time.Alternatively, if the user had access to the service password, the setting may have accidentally been enabled.The root cause is unknown.Risk management documentation was reviewed.The risks associated with running with an open door are found in baltrm-maxinst-aph rev 16.No new risks or changes to existing risks were discovered as a result of the complaint investigation.This type of complaint is trended as part of the code "service generated", which is also associated with other service related symptoms.During the month of november 2019, there were 5 service generated complaints reported.No other complaints pertaining to running with the door open or "service mode" enabled have been received in the past 6 months.The average number of "service generated" complaints is 5/month based on the last 12 months of data.The calculated alert level for these complaints is 9 and action level is 12.No new trends were detected.No additional actions are currently required.Quality will continue to monitor for trends.Root cause description: service accessible only feature enabled.Rationale no new risks, hazards, or trends.
 
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Brand Name
BD MAX¿ SYSTEM INSTRUMENT
Type of Device
INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
Manufacturer (Section D)
BECTON, DICKINSON & CO.
7 loveton circle
sparks MD 21152
MDR Report Key9494615
MDR Text Key205090405
Report Number1119779-2019-00120
Device Sequence Number1
Product Code OOI
UDI-Device Identifier00382904419165
UDI-Public00382904419165
Combination Product (y/n)N
PMA/PMN Number
K130470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number441916
Device Catalogue Number441916
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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