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

Model Number	2110
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: one device was retuned for repair in used condition.This device has not been serviced in the past.Customer's reported problem of alarming error code 42222 was verified by functional testing.Most probable cause is the main board.Replaced the main board and the device passed all functional tests after the repair.
Event or Problem Description
It was reported that there was an error code 42222.There was no patient involvement.

• Brand Name: CADD-SOLIS HPCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20192377
• Report Number: 3012307300-2024-08894
• Device Sequence Number: 20744047
• Product Code: MEA
• UDI-Device Identifier: 10610586039232
• UDI-Public: (01)10610586039232(11)111027
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 21-2112-0100-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2011
• 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