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

Model Number 21-2111-0402-51

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

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

Event Type  malfunction  

Manufacturer Narrative

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 the pump had volume accuracy issues.No patient injury reported.

Manufacturer Narrative

Other text: b3: unknown; no information has been provided to date.Additional information was received indicating the event occurred during routine maintenance.Updated a1, h6 health effects-health impact.Device evaluation.One device was returned for analysis in used condition.Visual inspection showed the tamper seal was removed, the lcd lens was scratched and the downstream occlusion sensor was bubbled.Functional testing involved three separate delivery accuracy tests and showed the device to be delivering within specification.Since no issues with the device were found, no root cause for the reported event could be determined and no repairs or actions were needed.A review of service history found the device had not previously been in for service.

• Brand Name: CADD SOLIS HPCA PUMPS
• Type of Device: PUMP, INFUSION
• 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: 16691541
• MDR Text Key: 312876616
• Report Number: 3012307300-2023-03657
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517154290
• UDI-Public: 15019517154290
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2111-0402-51
• Device Catalogue Number: 21-2111-0402-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1