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

Model Number 2120

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 07/04/2018

Event Type  malfunction  

Event Description

Information was received that the cadd solis vip pump leaked during therapy.The patient was affected and admitted as an inpatient due to a gap of treatment for 4 hours.On (b)(6) 2018 the 7 day bag sprung a leak in the tubing filter on day 4.The emergency 800 number directed them to turn off the pump.The following day the patient went to (b)(6) to be reconnected.Because the gap in treatment was over 4 hours they were re-admitted to (b)(6) as inpatient for 3 days.This is the standard protocol.The patient was connected to another 7 day infusion pump that sprung a leak in the tubing filter again on day 4 on (b)(6) 2018.They drove back to (b)(6) to fix the problem.They were off the meds less than 4 hours so it was not necessary to for her to be admitted.On (b)(6) 2018 they received a call that stated on the next cycle, the manufacturer would be providing a different type of tubing.On (b)(6) 2018 another leak in the tubing filter.Each occurrence costs them more in co-pays, deductibles, supplemental insurance, medicare, and travel expenses.No reported long term adverse effects.

Manufacturer Narrative

Initial report was submitted on 14-sep-2019 for this set with 3012307300-2018-03562 mfr number.Device evaluation summary: one cadd adminitration set lot number 3607843 was returned for analysis in used condition.Visual inspection of the set found no discrepancies.Leak testing on the samples received were performed using hydrostat vessel to look for unusual functions; a leak was observed fleeing from the air vent of the filter.The design history review was performed.Based on the evidence, the complaint was confirmed.The root cause could not be identified.Based on the investigation, the most probable root cause of the reported event are the filter was received damaged from the supplier.The filter became damage after the product left shm facilities.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7878444
• MDR Text Key: 120385071
• Report Number: 3012307300-2018-03562
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586042829
• UDI-Public: 10610586042829
• Combination Product (y/n): N
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0102-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CADD INFUSION SETS; CADD INFUSION SETS; CADD INFUSION SETS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR