MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number	2120
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: 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 information becomes available.
Event or Problem Description
It was reported that the device had a downstream occlusion after occlusion was removed.There was unknown patient involvement and unknown signs or symptoms experienced.
Additional Manufacturer Narrative
D9.Date returned to mfg: 23-oct-2024.Investigation summary: the affected device was returned for evaluation.Visual inspection performed.Dso (downstream occlusion) seal has a minor bubble.Functional testing performed.Customer's reported problem of "downstream occlusion" cannot be replicated.Event log recorded 306 times of high alarm displayed: downstream occlusion alarms.The most likely cause is the dso sensor.Replaced dso sensor to resolve report error.This device passed all functional tests after the repair.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION PUMP
• Common Device Name: 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: 20428068
• Report Number: 3012307300-2024-10924
• Device Sequence Number: 20735040
• Product Code: FRN
• UDI-Device Identifier: 10610586042836
• UDI-Public: (01)10610586042836(11)220517
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111275
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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 Model Number: 2120
• Device Catalogue Number: 21-2120-0102-78
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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