MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. CADD SOLIS VIP PUMP; PUMP, INFUSION

Catalog Number	21-2120-0103-78
Medical Device Problem Codes	Device Sensing Problem (2917); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 reportable information becomes available.
Event or Problem Description
It was reported that there was a cassette not attached error.The event occurred during testing.There was no physical damage reported.There was no patient involvement, and no harm/adverse event was reported.
Additional Manufacturer Narrative
One device was returned for repair in used condition.This device has not been serviced in the past.The event log showed multiple cassette not attached properly alarms.Even though the downstream occlusion (dso) and upstream occlusion (uso) sensors passed all functional testing, the downstream was scratched.Visual inspection found a scratched downstream occlusion sensor, which would cause intermittent issues.The downstream seal was also over glued.Replaced the dso sensor.The device passed all functional tests after the repair.

• Brand Name: CADD SOLIS VIP PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19483644
• Report Number: 3012307300-2024-04684
• Device Sequence Number: 8139386
• Product Code: FRN
• UDI-Device Identifier: 15019517096392
• UDI-Public: (01)15019517096392(11)170509
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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 Catalogue Number: 21-2120-0103-78
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2017
• 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