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

Model Number 2110

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

H3: device not received by manufacturer.B3: date of event is unknown.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device suddenly lost power and switched itself off while connected to a patient, the staff was unable to power up.Pump immediately exchanged with alternative cadd solis pump.No harm to patient, no delay in treatment.On inspection, pump failing to power up.Pump connected to ac power cable, still unable to switch on device.Rechargeable battery pack removed from pump and reinserted, still unable to power up.Connected to same ac power cable, battery indicator now at 75 percent.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause to be a depleted battery; however, this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD SOLIS PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS 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: 18498258
• MDR Text Key: 332886582
• Report Number: 3012307300-2024-00208
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517154993
• UDI-Public: 15019517154993
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2112-0402-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1