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

Catalog Number	21-2131-25
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: one device was received.A visual inspection found the device in good condition.During the functional testing, the reported problem could not be duplicated however, found the comm module to be at fault.It appeared as if the comm module was stuck in heat reduction mode.A malfunctioning wireless radio board was suspected to be at fault.The comm module was sent to the supplier for further investigation.The item is a purchased finished good and the dhr is the responsibility of the supplier.
Event or Problem Description
It was reported that the communication module was showing frequent "wireless connection error." when the error occurred, it did not allow the user to proceed with the use of the pump.The only way to clear the error was to physically remove the top hat and re-attach it.Even when the communication module was swapped with another pump, the error travelled with it.Reporter has verified that there were no insulation rubber tips left on the pins.The error occurred during the infusion, and nurse mentioned she swapped the pump to continue patient medication.The event occurred in a clinical setting and was noted in device history.There was patient involvement and no patient harm/adverse event reported.

• Brand Name: CADD ACCESSORIES
• 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; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20773804
• Report Number: 3012307300-2024-14009
• Device Sequence Number: 8088550
• Product Code: MRZ
• UDI-Device Identifier: 15019517171969
• UDI-Public: (01)15019517171969(17)240605(10)13409696
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: Health Professional
• Device Expiration Date: 06/05/2024
• Device Catalogue Number: 21-2131-25
• Device Lot Number: 13409696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown