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

Model Number 2120

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

It was reported that the device had a displaying error code occur.No patient injury was reported.

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 additional reportable information becomes available.Operator of device is unknown.No information has been provided to date.

Manufacturer Narrative

Other, other text: b5: additional information received on 23-aug-2022 via email and attached in complaint object: this pump arrived in for repair with error 41541 on display.No patient involvement was noted.Error could not be cleared; sent in for repair.H6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device was missing the tamper seal.Error was found in the device ehl (event history log) multiple times.The customer stated problem was duplicated.The latch lock optic flex circuit and mpu (memory protection unit) board were defective and they were replaced.The cause of the reported problem could not be determined.A dhr (device history review) was not performed because the results of the complaint investigation do not indicate a problem with the manufacture or last repair of the device.No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.Therefore, no manufacturing or service records review is needed., corrected data: d4: correction: model number: 2120.

• Brand Name: CADD SOLIS VIP AMBULATORY INFUSION SYSTEM
• 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; minneapolis, MN 55442
• MDR Report Key: 15158323
• MDR Text Key: 304833096
• Report Number: 3012307300-2022-14510
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586042829
• UDI-Public: 10610586042829
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0102-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1