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

Catalog Number	21-2131-01
Medical Device Problem Codes	Computer Software Problem (1112); Loose or Intermittent Connection (1371); Telemetry Discrepancy (1629)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.The reported lot# 18676925 was not found for the reported catalog# 21-2131-01.Therefore, expiration date and h4.Manufacture date are unknown; no information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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.
Event or Problem Description
It was reported that the device had an out-of-box failure, with the alarms for the wireless module having an intermittent connection.The device fault occurred upon opening at the hospital.The operator of the device was an icumed fse.This was not reported to fda.The issue was not resolved.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9: product received date 7/16/2024.H3: one device was returned for repair in used condition with complaint that device alarms for wireless module intermittent connection.The reported comm module was returned with its host pump and evaluated.Evaluation test found the failure occurring when tested on its host pump with the polemount capture mounted but not repeating when tested on a known good test solis pump.No problem found with the wireless connectivity functions of the comm module.Determined that the fault was with the host pump not the comm module.

• Brand Name: CADD SOLIS AMBULATORY PUMP ACCESSORY
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19807783
• Report Number: 9617604-2024-00591
• Device Sequence Number: 20706993
• Product Code: MRZ
• UDI-Device Identifier: 15019517173864
• UDI-Public: (01)15019517173864
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 12/04/2024

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 Catalogue Number: 21-2131-01
• Device Lot Number: 18676925
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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
• Patient Sex: Unknown