MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 BARD CRITICORE MONITOR

Model Number	000002N
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the criticore monitor was not reading the urine volume.
Additional Manufacturer Narrative
The reported issue was unconfirmed.There was no root cause for the reported issue.The monitor was operating properly.The monitor measured the volume, and calculated the flow rate correctly.The coin cell measured 3.023vdc and will be replaced due to age.No d cell batteries were returned.The coin cell was replaced, and the unit was hard reset.The d cell batteries were installed.The monitor passed all tests, it worked properly and is ready for use.Investigation indicated that the reported issue was not manufacturing or supplier related (use of device).The reported issue could not be reproduced and the device was functioning as expected.Dhr review not required.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.".
Event or Problem Description
It was reported that the criticore monitor was not reading the urine volume.

• Brand Name: BARD CRITICORE MONITOR
• Common Device Name: CRITICORE MONITOR
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8130652
• Report Number: 1018233-2018-05801
• Device Sequence Number: 2056178
• Product Code: EXS
• UDI-Device Identifier: 00801741080777
• UDI-Public: (01)00801741080777
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 000002N
• Device Catalogue Number: 000002N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1