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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DYMAX CORP. -2523003 CRITICORE FLUID OUTPUT & CORE TEMPERATURE MONITORING SYSTEM - MONITOR; CRITICORE MONITOR
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DYMAX CORP. -2523003 CRITICORE FLUID OUTPUT & CORE TEMPERATURE MONITORING SYSTEM - MONITOR; CRITICORE MONITOR Back to Search Results
Catalog Number 000002N
Device Problems Failure to Read Input Signal (1581); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the device was not reading the urine volume or temperature.The criticore monitor was swapped with a second criticore monitor and therapy was resumed on the second criticore monitor without any further issues.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the device was not reading the urine volume or temperature.The criticore monitor was replaced with a second criticore monitor was used to monitor the patient's urine volume and temperature without any further issues.
 
Manufacturer Narrative
The reported event was unconfirmed.The device was returned to bes/dymax for evaluation.The criticore was visually inspected upon receipt and was found to be in good overall condition and functions normally.The monitor powered on and the warranty label was intact.The monitor reads the 98.6 degree test probe and measures the 500ml container.The unit was tested for volume measurement by using the three test containers: 0ml, 500ml, 2100ml, and another test container that was filled slowly to measure the fluid added to the container.Each of the test containers were measured properly by the monitor.The reported event could not be duplicated as the monitor was reading volume and temperature correctly.The coin cell, and all d cell batteries were replaced.One battery door had broken guide rails and was replaced.The criticore was subsequently inspected and tested by bes-dymax in accordance with bes-dymax standard processes and procedures and was found to fully comply with all requirements and specifications.The monitor was returned to the customer.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "warning: the criticore monitor requires special precautions regarding emc and needs to be installed and put into service according to the emc information provided in the following tables.Portable and mobile rf communications equipment may affect the criticore monitor.Warning: the criticore monitor should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the criticore monitor should be observed to verify normal operation in the configuration in which it will be used.Warning: do not immerse or submerge the monitor or turn it upside down when cleaning.Caution: use only heavy-duty alkaline d cell batteries.Do not use rechargeable batteries.Do not incinerate batteries.Recycle or dispose of them properly.Contact bard for disposal information.Caution: improper orientation of the batteries within the battery pack can potentially damage the criticore monitor.Caution: state and federal regulations govern the packaging necessary for return of medical product which may have been contaminated.Refer to local, state and federal regulations when packaging the criticore monitor for return.Caution: there are no user serviceable components inside the criticore monitor.The user should not attempt to repair the criticore monitor.To do so may void the warranty and could result in erroneous monitor readings.Caution: use of cables or sensors other than those specified for use with the criticore monitor, except those sold by bard for use as replacement part or repair components, may result in increased emissions or decreased immunity of the criticore monitor.Caution: the criticore monitor should be recycled properly per european union directive 2002/96/ec on waste electronic and electrical equipment, january 27, 2003.Do not dispose with ordinary municipal waste." (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the device was not reading the urine volume or temperature.The criticore monitor was replaced with a second criticore monitor was used to monitor the patient's urine volume and temperature without any further issues.
 
Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.
 
Event Description
It was reported that the device was not reading the urine volume or temperature.The criticore monitor was replaced with a second criticore monitor was used to monitor the patient's urine volume and temperature without any further issues.
 
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Brand Name
CRITICORE FLUID OUTPUT & CORE TEMPERATURE MONITORING SYSTEM - MONITOR
Type of Device
CRITICORE MONITOR
Manufacturer (Section D)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer (Section G)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6294205
MDR Text Key66479342
Report Number1018233-2017-00265
Device Sequence Number1
Product Code EXS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 12/29/2017
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
Device Operator Health Professional
Device Catalogue Number000002N
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2017
Initial Date FDA Received02/01/2017
Supplement Dates Manufacturer ReceivedNot provided
Not provided
12/29/2017
Supplement Dates FDA Received02/23/2017
03/17/2017
12/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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