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

Model Number	2110
Medical Device Problem Codes	Degraded (1153); Failure to Sense (1559); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had a downstream occlusion (dso) & cassette not attached errors.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
E1: facility name (b)(6).Address line (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
One device was returned for repair.It was stated that the device had a downstream occlusion and cassette not attached errors.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The insulator on the ac connector has been removed and the upstream seal is torn.The lcd display is showing corrosion.A review of the event log showed 31 intermittent cassette not attached properly alarms.Moving the latch to the closed position would trigger the alarm.79 downstream occlusion alarms were logged and riming the admin set would trigger the alarm.The downstream and upstream passed all functional tests.Both up and downstream occluded when tested.The downstream sensor passed at 22 psi.No visual defects to the downstream occlusion sensor.The upstream seal did have a small hole.The latch was moved to the open and then closed position without any faults.All tests indicate that the upstream and downstream are working properly.The event log does collaborate with the complaint.The cause is not known, as the pump passed occlusion tests.No repairs were performed.

• 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: 20051800
• Report Number: 3012307300-2024-08078
• Device Sequence Number: 15464770
• Product Code: MEA
• UDI-Device Identifier: 10610586039232
• UDI-Public: (01)10610586039232(11)120703
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/14/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2012
• 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