MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; ACCESSORIES, PUMP, INFUSION

Catalog Number	21-2131-01
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.Functional testing was unable to duplicate the reported issue when connected to a known good operating pump; however, upon further investigation, failure often occurs with newly built pumps.The root cause was unable to be determined.
Event or Problem Description
It was reported that the wireless communication module had a damaged antenna cover assembly screws and cannot be disassembled to connect the battery.The event took place in the hospital.It was an out of box failure.There was no patient involvement.Evaluation of the device identified the module was operating as intended when tested on a known good operating solis pcea pump but, when attached to newly built pumps, it returned the same failure.The pump would intermittently fail to detect the wireless communication module battery during the power-up process resulting in wireless module intermittent connection with the pump message when powering-up with the ac power cord plugged in.

• Brand Name: CADD
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolise, MN 55442 ; 2247062300
• MDR Report Key: 20433558
• Report Number: 3012307300-2024-11011
• Device Sequence Number: 12664741
• Product Code: MRZ
• UDI-Device Identifier: 15019517173864
• UDI-Public: (01)15019517173864(17)240905(10)18798551
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: Other
• Device Expiration Date: 09/05/2024
• Device Catalogue Number: 21-2131-01
• Device Lot Number: 18798551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown