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

Model Number 000002N

Device Problems Incorrect Measurement (1383); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

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 device experienced an issue measuring the flow volume.

Manufacturer Narrative

The reported event of the device giving problems measuring flow volume was confirmed.The root cause of the reported issue was design control issues related to software versions (b)(4).The monitor was received at (b)(4) on 8/7/2017 for servicing.Engineering has extensively tested this unit to determine and correct the issues with the wave series criticore.The criticore waves have been put on an indefinite hold due to multiple unresolvable errors.The device will be returned and dispositioned under (b)(4).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 tables in section 9, emc compliance.Portable and mobile rf communications equipment may affect the criticore® monitor.The criticore®monitor may be interfered with by other equipment, even if that other equipment complies with cispr emission requirements.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.Warning: during long-term storage, remove primary batteries.Warning: to avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth.Caution: do not set alarm limits to extreme values that can render the alarms useless.Caution: use only 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.Refer to section 6, maintenance for instructions on how to return the monitor to bard for service and/or calibration.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 2012/19/eu on waste electronic and electrical equipment, july 4, 2012.Do not dispose with ordinary municipal waste.Caution: there are no serviceable components in the criticore® monitor.The user and/or service personnel should not attempt repair of the criticore® monitor.To do so, may void the warranty, and could result in erroneous monitor readings.Note: it is recommended that the monitor receive a maintenance inspection annually, including replacing the lithium coin cell, or more frequently as dictated by hospital protocol.The inspection must be performed at an authorized c.R.Bard, inc.Service facility.To arrange for service from c.R.Bard, inc., call 1-800-526-4455.Note: always perform a functional checkout of the criticore® monitor prior to putting the monitor into service after repair.".

Event Description

It was reported that device experienced an issue measuring the flow volume.

• Brand Name: BARD® CRITICORE® MONITOR
• Type of Device: CRITICORE
• 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: 6789885
• MDR Text Key: 82935472
• Report Number: 1018233-2017-04203
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741080777
• UDI-Public: (01)00801741080777
• 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,other
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

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 Model Number: 000002N
• Device Catalogue Number: 000002N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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