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

Model Number	2110
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that when trying to run the tests.The device would not recognise the cassette being locked.Pump will not run without cassette being locked.There was unknown, patient involvement.And unknown, patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: event date unknown.Device evaluation: one device was received.A visual inspection found, the dso seal damaged.During the functional testing, the problem stated, by the customer was replicated.Pump doesn't recognize the cassette.Device is not able to start with delivering.The cause of the issue was found to be the latch or latch sensor.The latch and latch sensor were replaced.A device history record (dhr) review reported, no discrepancies or non-conformances, during the manufacturing of the reported serial number.

• Brand Name: CADD SOLIS HPCA 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: 20771922
• Report Number: 3012307300-2024-13914
• Device Sequence Number: 17267874
• Product Code: MEA
• UDI-Device Identifier: 10610586038822
• UDI-Public: (01)10610586038822(11)140509
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: Other
• Device Model Number: 2110
• Device Catalogue Number: 21-2112-0300-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2014
• 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