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

Model Number 2120

Device Problem Calibration Problem (2890)

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

Event Type  malfunction  

Event Description

It was reported that during bench test, the device failed calibration.No patient injury was reported.

Manufacturer Narrative

Operator of device: is unknown.No information provided to date.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to any previous repair.Visual inspection of the device found the tamper seal missing.There was no evidence of the error found in the event history log.The customer reported problem failed calibration was not verified.Performed downstream and upstream fictional test, and the investigation found that both sensors functioned as intended.However, due to the high alarm found in the event history log, it was recommended replacing the downstream occlusion sensor as preventative measure.No fault was found with the device based on the reported problem.The root cause of the reported problem was unknown.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record review was not performed.Service history review identified this device has not been in for service previously., corrected data: correction: d4: model number: 2120.Correction: d4: catalog number: 21-2120-0104-01.

• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 11130 strang line road; minneapolis, MN 55442
• MDR Report Key: 15463707
• MDR Text Key: 306205888
• Report Number: 3012307300-2022-20077
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517126587
• UDI-Public: 15019517126587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1