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

Model Number 2110

Device Problems Device Alarm System (1012); Air/Gas in Device (4062)

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

Event Date 03/31/2024

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that during use, the device exhibited an unknown alarm and was stopped.The alarm was acknowledged and the pump restarted but the alarm persisted and then showed ¿remove and reattach cassette¿ but the cassette was locked.Per the patient, air bubbles were visible in the tubing.Further troubleshooting was attempted but the alarm persisted and the pump was powered off.Per the reporter, there was no patient harm.

• 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 Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19217225
• MDR Text Key: 341434968
• Report Number: 3012307300-2024-03196
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• 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: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2014
• 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