MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; PUMP, INFUSION

Model Number	2120
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during testing of this smiths medical cadd solis pump, the pump had blister on the downstream sensor.No patient injury reported.
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customers reported problem were found during the review of the service and repair records.A product sample was received for evaluation.Visual inspection showed tampered seal label was missing and downstream sensor seal was bubbled.The reported problem was verified.The downstream sensor seal was damaged, degraded and bubbled.The downstream sensor seal was replaced.

• Brand Name: CADD
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12863347
• Report Number: 3012307300-2021-11752
• Device Sequence Number: 1441313
• Product Code: FRN
• UDI-Device Identifier: 15019517150148
• UDI-Public: 15019517150148
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 21-2127-0105-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• 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