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

Model Number 21-2111-0402-51L

Device Problem Volume Accuracy Problem (1675)

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 was showing low accuracy.No patient injury reported.

Manufacturer Narrative

While performing a review of additional information provided by the customer, there was no patient involvement, therefore, no patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.File cc-0191349 is no longer considered reportable, please disregard any reports associated with it.

Event Description

Additional information was received that there was no patient involvement.

• Brand Name: :CADD SOLIS HPCA PUMP
• 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: 16722263
• MDR Text Key: 313129547
• Report Number: 3012307300-2023-03943
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517154986
• UDI-Public: 15019517154986
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2111-0402-51L
• Device Catalogue Number: 21-2111-0402-51L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1