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

Catalog Number 21-2111-0402-51

Device Problems Device Alarm System (1012); Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the battery docking was broken, and the air detection alarm failed.There was unknown patient involvement and unknown patient harm/adverse event reported.

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided to date.Investigaton summary: the affected device was received for evaluation and was visually inspected.It had a broken battery compartment and bubbled dso seal, confirming one of the customer's indicated failures.Functional testing was performed where the air detection alarm failed, confirming one of the customer's indicated failures.The root cause could not be determined.The issue was resolved by replacing the battery compartment and dso seal.The device has since passed functional and accuracy testing.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD SOLIS PUMP KIT
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19086450
• MDR Text Key: 339887383
• Report Number: 3012307300-2024-02388
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: (01)15019517154290(11)200506
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/10/2024

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 Catalogue Number: 21-2111-0402-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2020
• 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