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

Model Number	2120
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One pump was returned for analysis in used condition.Visual inspection of the pump showed that the pump was in good physical condition.Review of the device data log noted a "cassette not attached properly" alarm was recorded.Functional testing included use testing.The pump was powered on and exhibited a "cassette not attached properly" alarm after unlatching and latching the handle.Further investigation found fluid ingression on the downstream sensor.The downstream occlusion sensor was replaced.Based on the evidence, the complaint was confirmed.The root cause was attributed to fluid ingression.
Event or Problem Description
Information was received indicating that this ambulatory infusion pump exhibited a "cassette not attached" alarm.It was not specified whether or not this occurred during infusion or interrupted therapy.No adverse patient effects were reported.
Event or Problem Description
Additional information was received that: all errors were found during preventive maintenance (pm) testing, there was no patient involvement.
Additional Manufacturer Narrative
Other text: additional information is provided in b5 and h6.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD® CADD®-SOLIS VIP AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• 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: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8066546
• Report Number: 3012307300-2018-08238
• Device Sequence Number: 15064326
• Product Code: FRN
• UDI-Device Identifier: 15019517084368
• UDI-Public: 15019517084368
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0103-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown