MAUDE Adverse Event Report: ST PAUL CADD-SOLIS; PUMP, INFUSION, PCA

Model Number 2110

Device Problems Volume Accuracy Problem (1675); Inaccurate Delivery (2339)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One cadd®-solis ambulatory infusion pump was returned for analysis with a scratched screen.An accuracy test was performed in order to confirm the reported issue.The customer's concern regarding failed accuracy was unable to be confirmed.Delivery accuracy testing found the pumps average delivery error to be within the published specification.

Event Description

Information was received indicating that a smiths cadd®-solis hpca ambulatory infusion pump inaccurately delivers medications.There was no reported injury to the patient.

Manufacturer Narrative

Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Both tamper seals were broken.Scratched lens were found in visual observation.Errors were found in pump event history log.Accuracy test were unable to duplicate the reported problem.The root cause of the reported issue was not found due to being unable to duplicate the reported problem.Actions were taken to mitigate the reported issue: trimmed expulsor.

Event Description

It was reported that the device is showing inaccurate delivery.No patient injury was reported.

• Brand Name: CADD-SOLIS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8422674
• MDR Text Key: 138853009
• Report Number: 3012307300-2019-00626
• Device Sequence Number: 1
• Product Code: MEA
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0100-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1