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

Model Number 2120

Device Problems Excess Flow or Over-Infusion (1311); Device Difficult to Program or Calibrate (1496)

Patient Problem Overdose (1988)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Information was received that the cadd solis vip pump allows a programming error when the protocol is setup by a clinician or a nurse.In this case the programming error was made by the nurse.When she turned on the pump it was already on pca mode, she selected "view infusion parameters" and setup the continuous flow rate, the bolus dose and the residual volume; however she didn't change the concentration of the medication because the pump did not allow this change.She launched the infusion which last 2 hours and 20 minutes and there was an overdose of analgesic treatment (morphine-type medication) to the patient.The patient was delivered an antidote during the same day to avoid serious clinical consequences.Previously the concentration was set to 0.1 mg/ml, the pump ran and was stopped.On the current day the nurse entered new parameters of residual volume = 100ml, flow rate = 4.1 mg but she did not change the concentration because it was not possible in this pca mode.The correct concentration should have been 1 mg/ml in this case, but remained on 0.1 mg/ml.The customer confirms this is human error, but was complaining that the pump should not allow to modify only few parameters in the mode "view infusion parameters", he says all the parameters should be modifiable in mode "launch new/same patient" to avoid an error.No reported long term adverse effects.

Manufacturer Narrative

Additional information: updated fields: age or date of birth-ethnicity.The following additional information was received regarding the patient's medical history and state of health prior to the incident on (b)(6)2018: it was discovered the patient had a "lower lung neoplasia right with cerebral localization, right hemiparesis, and facial paresis with slurred speech".It was also noted the patient had waited "for histology for a start of chemotherapy" and consulted with a physician to move to palliative care.Furthermore, it was reported that on (b)(6)2018, the patient had "pm from morphine by pca 100mg / 24h at 10:44 and additionally, at 14:30, a light bulb of narcan following the incident and a second at 4:10 pm ms of hypnovel in addition to the 30/05/2018 at 14:53".Device evaluation information received on (b)(6)2018 : one cadd pump was returned for evaluation.The returned device was given functional and delivery testing: the testing showed the device met with specifications.The device event history log was extracted and examined.The investigation determined that the user set the concentration to 1 mg/ml at 4:26pm on 28 may.The user had already chosen this setting in an already established infusion protocol so this change caused the continuous rate to change.The investigation determined the user did not select "start new patient" as per device instructions.Based on the investigation, the complaint allegation was not confirmed.User interface was noted to be the problem source for the event.

• 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: 7795181
• MDR Text Key: 117565325
• Report Number: 3012307300-2018-03281
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0102-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 40