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

Catalog Number	21-2131-25
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date unknown.H4 unknown - unable to verify serial number.H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the dose cord input connection is not working and the communication has an intermittent signal.There was unknown patient involvement and unknown harm/adverse reported.
Additional Manufacturer Narrative
H6: updated.H3: one device was received.A visual inspection found the device in good condition with no noticeable damage.The device was tested on a known good cadd device and connected to wi-fi as expected with no alarms or errors.The customer reported complaint was unable to be duplicated and a root cause was unable to be determined.The item is a purchased finished good, and the dhr is with the supplier.Therefore, a manufacturing batch review could not be performed.

• Brand Name: CADD COMMUNICATION MODULE
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen street; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21573208
• Report Number: 3012307300-2025-02679
• Device Sequence Number: 15521991
• Product Code: MRZ
• UDI-Device Identifier: 15019517171969
• UDI-Public: (01)15019517171969
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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 Catalogue Number: 21-2131-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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