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

Model Number 21-2112-0402-51

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

It was reported, that the customer used the pump 2 times.And there were variances in the infusion amount, one greater than 7 percent.Both times were under infusions.User reported, seeing this by the amount left in the cassette.The biomed did a preventive maintenance testing, with no issues found.No patient injury reported.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr, 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other, other text: one device was received for evaluation.Visual inspection found the tamper seal to be removed, and the dso seal was bubbled.Review of the device's event history log was not applicable.An accuracy test was performed.Upon review, the reported problem was unable to be duplicated.The service history review identified no indication that the complaint was related to a service of the device within the review period.D3, g1,g2 email is: regulatory.Responses@icumed.Com.

• Brand Name: CADD SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17039217
• MDR Text Key: 316422430
• Report Number: 3012307300-2023-05935
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517154993
• UDI-Public: 15019517154993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2112-0402-51
• Device Catalogue Number: 21-2112-0402-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1