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

Model Number 2120

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

Patient Problems Hypoxia (1918); Overdose (1988); Decreased Respiratory Rate (2485)

Event Date 12/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Report source: (b)(6).

Event Description

Information was received indicating that a smiths medical cadd-solis vip ambulatory infusion pump over delivered.It was reported that the patient was started on dilaudid with hydromorphone 2:1 at 0.25 mg/hr infusion for dyspnea.It was also reported that previously the patient had received oral doses of dilaudid 1mg with ativan 1mg but that it had "no effect on their loc." per reporter, the infusion was started at 1630hrs and by 1915hrs the patient was unresponsive, pinpoint pupils, respiratory rate 6/min, spo2 48% 4l np and that at time, the infusion was stopped.It was reported that both the volume in bag and volume programmed into the pump was 50 ml, that approximately 2 ml was used for priming and that the pump displayed that 46.9 ml remained in the bag.It was reported that a pharmacist measured the amount remaining in the bag to be 44 ml.It was also reported that the delivery report showed the patient did not receive any pca or clinician boluses.Subsequently the patient was given two small doses of 0/05mg narcan and they improved.No additional adverse patient effects were reported.

Manufacturer Narrative

Device evaluation: one smiths medical cadd solis vip pump was returned for analysis in a good condition.During analysis, the customer's reported problem was not able to be duplicated and no problems were found.Based on the evidence, the complaint was not confirmed, and no fault was found.

• 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
• MDR Report Key: 8689325
• MDR Text Key: 147707000
• Report Number: 3012307300-2019-03248
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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: 21-2120-0100-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention