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

Model Number 2110

Device Problem Calibration Problem (2890)

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

Event Type  malfunction  

Event Description

It was reported that a pump failed an accuracy test.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Other, other text: b5: describe event or problem: updated with additional information received.H3: device evaluated by manufacturer: updated.H6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned to manufacturing for investigation.Visual inspection and functional testing were performed.Visual inspection of the returned device confirmed that the tamper seal was intact upon receipt.Error code was not found in the ehl (event history log).The customer reported problem was duplicated during the investigation as the pump was found to be overdelivering to specifications.Root cause of the reported event is unknown.The pumps expulsor needs to be trimmed in order to bring the delivery into specification.The returned product is beyond a year from the manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record dhr review is not required.

Event Description

Additional information was received by the manufacturer on 10-oct-2022 via email and attached to the complaint object: customer states that they just want to send in this device for repair, they did not submit a complaint file as there was no patient incident with the device.

• Brand Name: CADD SOLIS 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; attn: receiving; minneapolis, MN 55442
• MDR Report Key: 15540168
• MDR Text Key: 306586227
• Report Number: 3012307300-2022-20976
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: 10610586038808
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

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: 21-2112-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1