The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bd 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 bd.
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The reported issue was unconfirmed.The root cause of the reported issue could not be determined due to the inability to duplicate the issue.The monitor was put through a functional check during the evaluation in order to determine the root cause.The monitor functioned properly.The monitor read the 0ml, 500ml and 2100ml containers properly and calculated the flow rate properly.The left battery door had damage to the guide rails.Both battery packs measure less than 4.6vdc, which is the servicing minimum voltage.The battery door and d cell batteries were replaced.The ce update was performed.The monitor passed all tests, it is working properly and is ready for use.A device history record review was not required per the investigation.The instructions for use were found adequate and 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." h11:section a through f - the information provided by bd 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 bd.
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