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

Model Number 2120

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Stacking Breaths (1593); Fatigue (1849); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that the device under delivered the medication.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other, other text: b5: describe event or problem: updated with additional information received.B7: other relevant history, including preexisting medical conditions: updated with additional information received.H6: event problem and evaluation codes: updates are not required.H10: no sample has been received by manufacturing to date.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 Description

The reported issue occurred while in use with the patient.

Manufacturer Narrative

Other text: b5: additional information.H6: event problem and evaluation codes: updated.H10: device evaluation 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 Description

Additional information received on 06-dec-2022 via email and attached to complaint object: date of the event: 11/08/2022; the event occur during patient use; patient details updated in complaint; other relevant history, including pre-existing conditions history of ischemic cardiomyopathy, hepatitis c treated, htn (hypertension), hld (hyperlipidemia), colon polyps, carotid stenosis, endarterectomy; the event did not result in patient harm; medical intervention: on 11/2/22 patient was seen by cardiologist, where the patient presented with increasing sob (shortness of breath) and fatigue; the patient medication was adjusted.The outcome of the event was resolved.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause to be the disposable attached to the pump, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.Service history review identified this device has not been in for service previously.

• Brand Name: CADD SOLIS VIP AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; suite 10; minneapolis, MN 55442
• MDR Report Key: 15905822
• MDR Text Key: 307790568
• Report Number: 3012307300-2022-27714
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• UDI-Public: 15019517126587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/06/2022; 12/13/2022; 01/24/2023
• Supplement Dates FDA Received: 12/12/2022; 12/22/2022; 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White