MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UROS MONITOR

Model Number BK10001M

Device Problems Overfill (2404); Device Displays Incorrect Message (2591); 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 while on a patient, the cartridge was attached, and was overwhelmed by retained urine.The urine began overflowing into the bag, and the monitor was not able to cycle fast enough to capture all of the retained urine.The monitor over reported and under reported the volume of urine multiple times throughout the duration of use.The monitor also began receiving a tilt alarm, although the device was reportedly level.The monitor remained on the patient for the duration it was needed.

Manufacturer Narrative

The reported issue was confirmed.The device was returned to medivance following the event.The root cause of the reported issue of the meter overflowing was isolated to a design related issue.When the meter goes into overflow mode, the laser is unable to read the level of the urine as the overflow level is out of range of the laser; therefore, the monitor is not able to cycle and drain the meter completely.This limits the drainage rate of the meter to only the overflow drain tube which can cause urine to back up the drainage tubing.The device will not be repaired as the customer declined repair.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: "indications for use the uros¿ automated urine output and temperature monitor is indicated to monitor urine output and core bladder temperature.Contraindications: there are no known contraindications for the use of the uros¿ automated urine output and temperature monitor.Warnings: the uros¿ automated urine output and temperature monitor requires special precautions regarding emc and needs to be installed and put into service accordingly.Portable and mobile rf communications equipment may affect the operations of uros¿ automated urine output and temperature monitor.The uros¿ automated urine output and temperature monitor should not be used adjacent to or stacked with other equipment.If it is absolutely necessary to use the uros¿ automated urine output and temperature monitor in close proximity with other equipment, the uros¿ automated urine output and temperature monitor should be observed to verify normal operation in the configuration in which it will be used.Do not immerse or submerge the uros¿ automated urine output and temperature monitor or turn it upside down when cleaning.When shipping the uros¿ automated urine output and temperature monitor for service or repair: remove battery module from device to prevent battery leakage.Package battery module separately in a non-conductive bag.Place warning label on the outside of the shipping package (see section 8, shipping lithium batteries).User shall not place the uros¿ automated urine output and temperature monitor within the sterile field.Cautions: federal law (usa) restricts this device to sale by or on the order of a physician.Use only a uros¿ automated urine output and temperature monitor compatible battery.Do not incinerate batteries.Recycle or dispose of them properly.Contact bard® for disposal information.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 uros¿ automated urine output and temperature monitor for return.There are no user serviceable components inside the uros¿ automated urine output and temperature monitor.The user should not attempt to repair the uros¿ automated urine output and temperature monitor.To do so may void the warranty and could result in erroneous monitor readings.For service and/or repair, call bard® customer service at: 1-800-526-4455, u.S.Only.Use of cables or sensors and other accessories other than those specified for use with the uros¿ automated urine output and temperature monitor, except those sold by bard® for use as a replacement part or repair components, may result in increased emissions or decreased immunity (more susceptible to equipment interference) of the uros¿ automated urine output and temperature monitor to electromagnetic interference.The uros¿ automated urine output and temperature monitor should be recycled properly per european union directive 2012/19/eu on waste electronic and electrical equipment, july 4, 2012.Do not dispose with ordinary municipal waste.Regulations and laws pertaining to the recycling and disposal of lithium ion batteries and battery modules vary widely from country to country, as well as by state and local governments which may have additional requirements.Please dispose of in accordance with state and local procedures.Uros¿ battery module: do not open, crush, or heat the battery module above 50°c or incinerate.Risk of fire and burns.Store pack at -20°c to 50°c.Avoid kicking or knocking over the monitor with foley bag attached.Avoid placing the uros¿ automated urine output and temperature monitor on the bed.Always pause the uros¿ automated urine output and temperature monitor utilizing the user interface when transporting the patient or replacing the bag.The uros¿ automated urine output and temperature monitor shall be used with the provided mounting options.The mounting options shall only be used with the uros¿ automated urine output and temperature monitor.It is recommended that the uros¿ automated urine output and temperature monitor receive a maintenance inspection annually or more frequently as dictated by hospital protocol.The inspection must be performed at an authorized bard® service facility.To arrange for service from bard®, call 1-800-526-4455.Always perform a functional checkout of the uros¿ automated urine output and temperature monitor prior to putting the monitor into service after repair.The uros¿ automated urine output and temperature monitor is designed for use with only bard® products (surestep¿ foley tray systems and the uros¿ precision urine output meter).The uros¿ automated urine output and temperature monitor is designed for use only with the provided external power supply (see section 9: replacement / spare parts).Medical electrical equipment needs special precautions to minimize electromagnetic interference.The following are manufacturer¿s guidance: the use of accessories or cables other than those specified or sold by bard® is not recommended.Use of unapproved accessories or cables may result in increased emissions or in decreased immunity of the uros¿ automated urine output and temperature monitor to electromagnetic interference.If the uros¿ automated urine output and temperature monitor is used directly adjacent to other equipment, the user should periodically observe the uros¿ automated urine output and temperature monitor to verify it operates normally in that environment.Portable and mobile rf communications equipment can affect medical electrical equipment.The uros¿ automated urine output and temperature monitor contains a class 3r laser.Class 3r lasers are considered safe when handled carefully.A class 3r laser is low powered.There is only a small hazard potential for accidental exposure.It normally would not harm eyes during a momentary exposure of less than ¼ second.This is within the aversion response, where a person turns away and/or blinks to avoid bright light.Do not deliberately look or stare into the laser beam.Laser protective eyewear is normally not necessary." (b)(4).

Event Description

It was reported that while on a patient, the cartridge was attached, and was overwhelmed by retained urine.The urine began overflowing into the bag, and the monitor was not able to cycle fast enough to capture all of the retained urine.The monitor over reported and under reported the volume of urine multiple times throughout the duration of use.The monitor also began receiving a tilt alarm, although the device was reportedly level.The monitor remained on the patient for the duration it was needed.

• Brand Name: UROS MONITOR
• Type of Device: UROS MONITOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6555495
• MDR Text Key: 74898046
• Report Number: 1018233-2017-02312
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741104947
• UDI-Public: (01)00801741104947
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BK10001M
• Device Catalogue Number: BK10001M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1