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

Model Number	21-2131-01
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was not returned for analysis.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 during testing a pole clamp bracket caused intermittent connection to module.There was no patient involvement or injury reported.
Additional Manufacturer Narrative
Other, other text: b5: additional information received and attached by icu medical on (b)(6).2022 via email: shipping address, device location and contact info.The customer communicated lot number could not be validated in the database so the manufacturing date could not be completed (h4).
Additional Manufacturer Narrative
D4: lot number provided was deemed invalid.No information provided to date.A device history record review was not performed, as the lot number provided was deemed invalid.Visual inspection was performed, and the following observations were noted: no damage noted.Returned in new and unused condition.Testing was conducted, which included: configured the pump's wireless settings using the network setup utility.The pumps and the computer were connected to the test wireless network and pinged the pump to initiate data transfer.Test pole clamp bracket adapter was attached to the module, as the customer did not return their pole clamp bracket.All data packets sent to the pump were transferred successfully.The reported issue was not confirmed.The root cause of the reported event was unable to be determined.

• Brand Name: CADD SOLIS AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14946152
• Report Number: 3012307300-2022-13033
• Device Sequence Number: 6215603
• Product Code: FPA
• UDI-Device Identifier: 15019517173864
• UDI-Public: 15019517173864
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2022

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: 21-2131-01
• Device Catalogue Number: 21-2131-01
• Device Lot Number: 11096856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 07/08/2022; 10/14/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 07/27/2022; 10/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown