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); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the right side cassette pin on the device was lodged or stuck and the device alarmed that the cassette was not locked.It is unknown if there was patient involvement, no adverse patient effects were reported.

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.

Manufacturer Narrative

Other, other text: one device was received for evaluation.Visual inspection found a scratched lens, missing ring, worn uso seal, bubbled dso seal, and stuck cassette pin.There was no evidence to review in the device's event history log.Functional testing was conducted.Upon review, the reported problem was duplicated, the cassette pin was found to be stuck, causing the false alarm of cassette attached.It was determined that the root cause was due to the corroded cassette detector pins.The cassette detector pins were replaced.The 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 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: 18012195
• MDR Text Key: 326623572
• Report Number: 3012307300-2023-09928
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586039232
• UDI-Public: 10610586039232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072144
• 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: 11/29/2023

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: 21-2112-0100-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1