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

Model Number 2110

Device Problem Device Alarm System (1012)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

One device was received for evaluation.Visual inspection found a bubbled dso seal.Multiple 'downstream occlusion' alarms were found in the event history log.Functional testing was unable to duplicate the reported problem; however, the issue was verified in the ehl.It was determined that the most probable cause was the faulty dso seal and was replaced.The service history review identified no indication that the complaint was related to a service of the device within the review period.

Event Description

It was reported that a purge problem with a 250 ml cassette pump, causing an occlusion alarm.The alarms were recurrent and not present with 100 ml cassettes.The pump was used for iv antibiotic treatment and pca oxycodone.Troubleshooting was performed but the alarm persisted.The pump was checked with 100 ml cassettes, but no alarm was triggered.There was patient involvement, and no patient harm was reported.

• Brand Name: CADD SOLIS HPCA 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19112293
• MDR Text Key: 340815599
• Report Number: 3012307300-2024-02609
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 21-2111-0200-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2011
• 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
• Patient Age: 60 YR
• Patient Sex: Female