MAUDE Adverse Event Report: ST PAUL CADD SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Model Number 2110

Device Problem Loss of Data (2903)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: unknown; no information has been provided to date.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 the pump was not retaining the configuration due to a bad internal battery.It is unknown if there was patient involvement or if there were any adverse patient effects.

Manufacturer Narrative

One device was received for evaluation.Visual inspection found the tamper seal was broken, a scratched lcd lens, and a ripped dso seal.Pump settings and patient data lost" was found in the device's event history log.Functional testing was conducted.Upon review, the reported problem was duplicated.The internal rechargeable battery is designed to last for 10 years, it cannot hold charges anymore before patient data is lost.It was determined the internal battery is the root cause as it cannot hold a charge or patient data.The pwa board was replaced.The service history review identified an indication that the complaint was related to a service of the device outside of the review period.

• Brand Name: CADD SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17905443
• MDR Text Key: 325295605
• Report Number: 3012307300-2023-09207
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• 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: 21-2111-0100-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1