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

Model Number 2110

Device Problems No Audible Alarm (1019); Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Manufacturer Narrative

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 failed accuracy testing at 4.7 ml.It was also reported that the pump was "not occluding." the issue was found during testing, there was no patient involvement.

Manufacturer Narrative

Other text: one device was received for evaluation.Visual inspection found the tamper seal to be missing, a scratched lcd lens, worn keypad overlay, and a bubbled dso seal.There was no evidence in the device's event history log.Three accuracy tests were performed.Upon testing, the reported problem was unable to be duplicated.The service history review identified no indication that the complaint was related to a service of the device within the review period., corrected data: a1 corrected.

• 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: 17599494
• MDR Text Key: 321729180
• Report Number: 3012307300-2023-08269
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: 15019517099690
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• 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: 21-2111-0401-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1