MAUDE Adverse Event Report: ICU MEDICAL, INC CADD SOLIS COMMUNICATION MODULE; 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	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi unavailable as no item number was provided.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 device had a wireless intermittent signal.There was unknown patient involvement and unknown harm/adverse event reported.
Additional Manufacturer Narrative
The communication module was returned in good condition, with no physical damage observed.Upon initial receipt, the device was charged at 100%.Functional testing was performed, and the reported issue was not duplicated.A definitive root cause could not be determined.Upon powering on the device, it successfully connected to the local wi-fi network.The device remained powered on for 30 minutes while the wireless status was monitored, during which it consistently showed as "associated" with no errors reported.No action was taken.

• Brand Name: CADD SOLIS COMMUNICATION MODULE
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20976570
• Report Number: 3012307300-2024-15106
• Device Sequence Number: 4033045
• Product Code: MRZ
• UDI-Device Identifier: 15019517171969
• UDI-Public: (01)15019517171969(17)240605(10)12798149
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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
• Device Lot Number: 12798149
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown