MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Model Number 2110

Device Problem Volume Accuracy Problem (1675)

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

Event Type  malfunction  

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.

Event Description

It was reported that the device failed the volume test warranty during a service order service.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other, other text: d10: device available for evaluation: updated.H3: device evaluated by manufacturer: updated.H6: event problem and evaluation codes: updated.H10: device evaluation: a sample 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 missing upon receipt, there was no physical damage or issues noted.No error code was found in the ehl (event history log).The customer reported issue was not duplicated during the investigation as, after running three accuracy tests, the pump was found to be within manufacturing specifications.Root cause of the reported issue is unknown as there was no problem found.No actions or repair was needed.The 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 was not performed.Service history review identified this device has not been in for service previously.

• Brand Name: CADD SOLIS VIP AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15523098
• MDR Text Key: 306286350
• Report Number: 3012307300-2022-20607
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517154290
• UDI-Public: 15019517154290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0402-51
• 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: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1