MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. CADD SOLIS COMM MODULE; ACCESSORIES, PUMP, INFUSION

Catalog Number	21-2131-25
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Wireless Communication Problem (3283); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cadd solis pump with the 2131 communication module gave an error for "wireless module intermittent connection to pump".The alarm seemed very random but only came on when connected to ac power supply.This made sense if the battery pack was somehow getting disconnected.When not connected to ac power supply, the unit simply shut down with no alarm.All connections were clean, and the plastic contact covers were removed between the communication and the pump.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.There were multiple common device names and corresponding pro-codes associated with this device.The additional names and codes are listed below: d2a.Common device name: set, administration, intravascular.D2b.Procode: fpa.D2a.Common device name: accessories, pump, infusion.D2b.Procode: mrz.D2a.Common device name: pump, infusion, pca.D2b.Procode: mea.D4.Primary udi number: the primary di# has been used as the expiration date is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.H4.Device mfg date: the reported lot# 13409696 could not be found for the reported catalog# 21-2131-25; therefore, the manufacturing date could not be determined.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
D9 - date returned to mfg: 1/27/2025.One device was returned for analysis.Review of the event history log (ehl) showed a multiple occurrences of communication module intermittent connection.Functional and visual tests were performed, and the reported issue was not duplicated.The complaint is currently being investigated.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD SOLIS COMM MODULE
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21102987
• Report Number: 3012307300-2025-00410
• Device Sequence Number: 20996912
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: Health Professional
• Device Catalogue Number: 21-2131-25
• Device Lot Number: 13409696
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CADD SOLIS HPCA PUMP KIT 2110
• Patient Sex: Unknown