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

Catalog Number SCCS1002

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the bag volume percentage of several sensica device was buggy and inaccurate.Biomed witnessed once where the bag was removed to move sensica device.It was stated that when the bag was placed back on the ring, the bag volume percentage dropped to 0 percent.A nurse complained that one sensica unit would turn on and immediately showed a low battery alarm and then it shut off.The representative investigated this issue and found that detaching and reattaching all the power connections resolved the issue.Another nurse complained that another sensica unit was not turning on.Biomed investigated the issue and found that detaching and reattaching all the power connections resolved the issue.Several nurses complained that the monoplug adapters were too tight and could not be easily disconnected, or often disconnected at all.Two nurses complained that the instant update alarm would be dismissed and repeatedly reappeared making an annoying amount of noise for both the clinician and the patient.It was also reported that several nurses commented during training that the ring removal tab was not clearly indicated and difficult to see, making it difficult to remove the ring.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - 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 bag volume percentage of several sensica device was buggy and inaccurate.Biomed witnessed once where the bag was removed to move sensica device.It was stated that when the bag was placed back on the ring, the bag volume percentage dropped to 0 percent.A nurse complained that one sensica unit would turn on and immediately showed a low battery alarm and then it shut off.The representative investigated this issue and found that detaching and reattaching all the power connections resolved the issue.Another nurse complained that another sensica unit was not turning on.Biomed investigated the issue and found that detaching and reattaching all the power connections resolved the issue.Several nurses complained that the monoplug adapters were too tight and could not be easily disconnected, or often disconnected at all.Two nurses complained that the instant update alarm would be dismissed and repeatedly reappeared making an annoying amount of noise for both the clinician and the patient.It was also reported that several nurses commented during training that the ring removal tab was not clearly indicated and difficult to see, making it difficult to remove the ring.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO MONITOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13010320
• MDR Text Key: 282978491
• Report Number: 1018233-2021-08087
• Device Sequence Number: 1
• Product Code: EXS
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other