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

Model Number	21-2131-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was 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 an error code/depleted battery keeps occurring, but the battery is fully charged.There was no patient injury reported.
Additional Manufacturer Narrative
Other, other text: b5: additional information received on 13september2022 via email and attached to complaint object: no patient involvement.It failed when the service technician came out to set up all the wireless modules.H6: event problem and evaluation codes: updated.H10: a dhr review is not applicable in this case because the defective component comm module battery is not evaluated or tested in any way during our internal manufacturing process and the comm module's manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.A product sample was received for evaluation.Visual and functional testing were performed.No physical damage was noted.The comm modules were returned in brand new and unused condition.During function testing no connection failure or battery depleted error were observed even as the pump ran.However, a battery life test was performed and failed with an inadequate run time.Therefore the complaint was confirmed and the root cause was found to be a defective supplier battery.The event will be forwarded to the supplier for review.

• Brand Name: CADD SOLIS VIP 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): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15056473
• Report Number: 3012307300-2022-13655
• Device Sequence Number: 4784213
• Product Code: FPA
• UDI-Device Identifier: 15019517173864
• UDI-Public: 15019517173864
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 11680659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/07/2022
• 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