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

Model Number 2110

Device Problems Device Alarm System (1012); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2023

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 device exhibited a cassette latch error.It is unknown if there was patient involvement, no adverse patient effects were reported.

Manufacturer Narrative

Other text: one device was returned for analysis.Visual inspection showed the battery door was missing, scratched lens and a worn uso seal.The tamper seal was not broken.There was no evidence to review in the device's event history log.A functional test was performed and the reported issue was duplicated.When the cassette was attached to the pump, the device alarmed cassette not attached properly.The dso sensor output was stuck with no pressure.It was determined that the most probable cause was due to the dso sensor.As a result, the dso sensor was replaced.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.B3 and h3 were updated, d3, g1, and g2 email is: regulatory.Responses@icumed.Com.

• 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: 18068483
• MDR Text Key: 327323533
• Report Number: 3012307300-2023-10225
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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: 11/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1