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

Model Number 2110

Device Problems Insufficient Flow or Under Infusion (2182); Communication or Transmission Problem (2896); Connection Problem (2900); Loss of Data (2903)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that the device did not recognize the cassette and data loss/the comm module was not communicating.It is unknown if there was patient involvement, no adverse patient effects were reported.

Manufacturer Narrative

B3: event date unknown.H3: device not received by manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

No lot number was provided; therefore, a history record review could not be conducted.D4: udi and model number are unknown, d3, g1, and g2 email is: regulatory.Responses@icumed.Com.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18425966
• MDR Text Key: 331883825
• Report Number: 3012307300-2024-00002
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0100-51
• Device Lot Number: 4321040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2013
• 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
• Treatment: CADD MEDICATION CASSETTE.
• Patient Age: 45 YR
• Patient Sex: Female