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

Model Number 2110

Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown; no information has been provided to date.One device was received.No physical damaged was found on the device.A review of the history log confirmed that no miss setting, or other errors related to delivery failures were identified.During functional testing, the pump accuracy was within specification however, it confirmed that it was close to the upper limit of the reference value and tended to overdose.The complaint was confirmed.Possible flow rate accuracy failure related to pump mechanism.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Adjustment of the expulsor.Performed all function tests and all passed.

Event Description

It was reported that the flow accuracy exceeds.There was patient involvement and unknown patient harm/adverse event reported.

• Brand Name: CADD SOLIS HPCA PUMP
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19099790
• MDR Text Key: 340805880
• Report Number: 3012307300-2024-02547
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• 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: 21-2111-0300-09JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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