MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD-SOLIS HCPA PUMP; PUMP, INFUSION, PCA

Model Number	2110
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.The device was received for evaluation.A visual inspection noted that the device was in good condition.Functional testing and visual tests were conducted with the returned device and the customer problem was duplicated as the upstream occlusion sensor (uso) alarmed when testing the uso.The root cause of the problem was the upstream occlusion sensor.No issues were found in the event history log.The service history review identified the device has not been in service within the review period.As a result, the upstream occlusion sensor was replaced.
Event or Problem Description
It was reported that the device was for service repair.There was unknown patient involvement and unknown patient harm/adverse event reported.Analysis identified an upstream occlusion sensor alarm was malfunctioning.

• Brand Name: CADD-SOLIS HCPA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19711248
• Report Number: 3012307300-2024-05938
• Device Sequence Number: 18293764
• Product Code: MEA
• UDI-Device Identifier: 10610586038822
• UDI-Public: (01)10610586038822(11)140325
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: 2110
• Device Catalogue Number: 21-2112-0300-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown