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

Model Number 2110

Device Problems Excess Flow or Over-Infusion (1311); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that that the mechanism was not working and there was no flow.Additionally, per reporter, after testing the average delivery, the results indicated that the pump was over delivering.No adverse patient effects were reported.It is unknown if the event of no flow occurred during use with a patient.

Manufacturer Narrative

Other text: b3: unknown; no information has been provided to date.D4: udi number and g5 are unavailable.G3: france.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

One device was returned for analysis.Visual inspection showed a broken display lens.The tamper seal was not broken.An occlusion and functional test were performed and the reported issue was not duplicated.Investigation found no issues with the device delivering.The pump was tested and was found to be functioning properly and delivering within specification.A service history review identified no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD SOLIS HPCA 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: 17607133
• MDR Text Key: 321779525
• Report Number: 3012307300-2023-08335
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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: 21-2112-0300-02
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1