MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA POWER CORD REPLACEMENT KIT

Catalog Number SSRK1008

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

It was reported that the wires of sensica¿s power cord were exposed.Per there were 3 power cords given by the nursing staff from the unit where they witnessed sparks coming from the power cord.The exposed copper was found consistent in all 3 sets of cords.Customer would send us the incident reports so that we have dates on file in which these incidents occurred.

Manufacturer Narrative

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

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be user related due to inadequate securement of power cord to system.However, this cannot be confirmed.Device was visually evaluated and it was confirmed that the unit power cords had exposed wires.Images of the sample after evaluation are attached.At the time of failure, the power cords were replaced with functioning ones.Therapy was continued on same device with new power cord.The device was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: the power cord assembly for the bd sensica¿ urine output system plugs into the base of the stand.The cable tie is provided for convenience in keeping the power cord attached to the system.The tie is connected to the power plug at the plug end.Additional slots in the cable tie allows the cable to be used to tie the entire power cord assembly to the system stand.Correction: d,f,h.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 h3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the 3 power cords of sensica device¿s power cord were exposed.Nursing staff witnessed sparks coming from those 3 power cords while in operation in the intensive care unit (icu).The exposed copper was found consistent in all 3 sets of cords.Customer would send us the incident reports so that we have dates on file in which these incidents occurred.Per follow up information received on (b)(6) 2022, serial numbers are not available for any of the sensica devices as the power cords were removed at the time of failure and replaced with functioning cords.The cords have been sent to bd.All three events involved patients as the device had to be disconnected from power at the point of care while a new power cord was obtained.Only one cord sparked.There were no patient injuries.

• Brand Name: SENSICA POWER CORD REPLACEMENT KIT
• Type of Device: SENSICA POWER CORD REPLACEMENT KIT
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15123679
• MDR Text Key: 302497839
• Report Number: 1018233-2022-05840
• 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: 09/22/2022

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 Catalogue Number: SSRK1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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