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

Model Number 2120

Device Problems Insufficient Flow or Under Infusion (2182); Intermittent Infusion (2341)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

H3: device not received by 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 information becomes available.

Event Description

It was reported that when the patient presented for pump disconnect, the bag still had approximately 38ml (967.7mg) of medication.The pump was checked for any log errors and it was noticed that it was intermittently pausing the infusion.Correct settings were confirmed.Per the reporter, there were no adverse patient effects.

Manufacturer Narrative

No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause is the main board; however, this cannot be confirmed as no product was returned for investigation.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• 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: 18813204
• MDR Text Key: 336651531
• Report Number: 3012307300-2024-01112
• Device Sequence Number: 1
• Product Code: FRN
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• 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