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

Model Number 2120

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Vomiting (2144); Dizziness (2194); Lethargy (2560)

Event Date 01/23/2023

Event Type  Death  

Manufacturer Narrative

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 while a smiths medical pump was being used with the patient, the patient experienced dizziness, lethargy and vomiting.The patient's family called 911 and the patient was taken to the hospital where it was found that the medication bag was empty.Customer states the bag was not supposed to be empty until the next day.The patient was admitted to the hospital and expired three days later.The customer tested the pump and they determined that the bag and tubing had 12.75ml even though the pump read that there was 58ml left.

Manufacturer Narrative

Device evaluation: the product was returned for evaluation.The customer's reported problem was not duplicated.Running three accuracy tests, the pump was found to be within manufacturing specifications.Priming the device, the downstream sensor occluded at 12 psi and the pressure held all three times.There appears to be no visual defects with the expulsor, valves, or chassis.The latch lock worked as it should.The delivery functions as it should.There were no abnormal events after investigating the history logs.A review of the manufacturing device history record (dhr) for this device found no causes or potential causes of the customer reported failure.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

Event Description

Additional information was received that the bag was confirmed to have been filled to 500 ml.It was manually primed in the clean room; the priming volume was not noted.It could not be confirmed if the bag under pressure during the infusion or significantly higher than the patient; and it was used of the same set for 7 days prescribed by the hcp.

• Brand Name: CADD SOLIS VIP AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• 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: 16368582
• MDR Text Key: 309460741
• Report Number: 3012307300-2023-01205
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517126600
• UDI-Public: 15019517126600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2120
• Device Catalogue Number: 21-2127-0104-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Death