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

Catalog Number 21-2112-0402-51

Device Problems Device Alarm System (1012); Failure to Sense (1559)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided 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

It was reported that the was a proximal occlusion.The fault's occurrence was unknown.There was unknown patient involvement and no harm/adverse event reported.

Manufacturer Narrative

One device was returned for evaluation.Visual inspection revealed the device in used condition.No applicable evidence was found in the event history log.Functional testing was unable to replicate the reported issue; however, a worn upstream occlusion (uso) sensor seal was found and was the probable cause of the issue.The uso sensor seal was replaced and sensor calibrated.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 PUMP KIT
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19191670
• MDR Text Key: 341437433
• Report Number: 3012307300-2024-03053
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517154993
• UDI-Public: (01)15019517154993(11)220825
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 21-2112-0402-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1