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

Model Number 21-2111-0402-51

Device Problems Mechanical Problem (1384); Product Quality Problem (1506); Application Program Problem (2880)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: 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 keeps switching during continues delivery.?no adverse patient effects were reported by the customer".

Manufacturer Narrative

One device was returned for analysis.Visual inspection showed no cracked cases.The tamper seal was removed.Review of the event history log (ehl) showed a ?low alarm displayed." the device was powered and the customer's settings were checked as part of the functional test and the reported issue was duplicated.The current "clinician bolus limits" was set to 10 ml and multiple "delivery limited reached" alarm messages were in the device's event history logs.The caused of the reported issue was no fault found due to customer's settings.A service history review identified no indication that the complaint was related to a service of the device within the review period.B3 unknown, h3 updated, corrected data: h6: health effects.

• 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: 16906519
• MDR Text Key: 314947651
• Report Number: 3012307300-2023-05156
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• 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: 05/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1