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

Model Number 2110

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the pump was not recognizing the cassette being latched.Patient involvement unknown.

Manufacturer Narrative

Other text: b3: date of event is unknown.Device evaluation: one device was received.A visual inspection found the tamper seal removed, a scratched lens, bubbled dso seal, and a worn uso seal.A review of the event history log found a "cassette locked but not latched" message.During the functional testing, the customer reported problem was able to be confirmed.The latch lock sensor was tested and it was found that it was unable to read if cassette is latched.The latch lock sensor was replaced.The product's history records were reviewed and there were no non-conformance's nor service-related issues that would have resulted in the reported complaint.

Event Description

Additional information received via email.It was reported that no further information is available.

• Brand Name: CADD SOLIS VIP AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17981002
• MDR Text Key: 326235493
• Report Number: 3012307300-2023-09830
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• 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: 11/10/2023

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: Other
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1