MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Dizziness (2194)

Event Date 04/01/2023

Event Type  Injury  

Event Description

We have had patients experiencing severe symptoms with cadd cassette exchanges.Please indicate your availability to meet today.We are meeting throughout the day and at 5pm with our medical intensivists, pharmacy, corporate supply chain, safety and quality.Product 21-7302-24, cadd 100ml cassette lot 4349146 exp: [redacted date].Patient 1: nausea & headache around cassette exchange time.Patients 2 and 3: these patients are new to remodulin this admission and are getting severe hypotension requiring pressors to support them.They have their remodulin doses titrated down and weaned off pressors.Treatment that has been required to resolve symptoms: added pressors, moved to icu, profound hypotension (symptoms are not uncommon, but are not this severe) there are 3 patients requiring exchanges today.We have our critical care mds and pharmacy teams on high alert.Internal investigation progress dual sign off (two rns at time of exchange) to ensure no human error ruled out this being related to compounding unsure if related to the pump keeping cassettes to look at the remaining volume to ensure patients are receiving intended volume.Clinical engineering will inspect the sets still loaded in the pumps (after exchange) to rule out mechanical causes we have confirmed (for the most recent two exchanges) these cassettes are not among the affected lot numbers for the recent recall and do not present clinically as we would expect from the recall.[redacted link].Other considerations could this be related to the previous recall at all? are patients getting a lower rate by the end of the infusion? is there a bolus unintentionally being administered when the cassette is removed/placed? other pumps may be an alternative, pharmacy is testing this possibility, but they would not be appropriate for continuation of home therapy.Our pharmacy has escalated a pending order with smiths/icu medical for unaffected lot replacement supply: purchase order: 51667122.One patience scenario: patient was transferred to sdu from the micu at 1215 on remodulin gtts infusing at 8 ng/kg/min with a rate 40 ml/24hr.Remodulin cartridge expired and at 1215, pharmacy was notified previous to expiration.Remodulin was delivered at 1315 and new cartridge was exchanged at 1336 with[redacted name], rn.Med dose, concentration and rate was verified to be correct prior to admission of the medication.Patient bp goal was maintaining until 1415, with map's in 30-50 with blood pressure cuff on left leg and reconfirmed on the left arm.Patient was symptomatic with dizziness and light headedness.Coach rn and i were at bedside at this time, along with the covering provider, [redacted name], md.This same provider then ordered peripheral norepinephrine, and map goal of > 60 were met on a levo gtts rate of 0.4 mcg/kg/min, then titrated down to a rate of 0.2 mcg'/kg/min.This patient was then subsequently transferred back to the micu.Manufacturer response for cadd infusion pumps and cassettes, cadd 100ml cassette and cadd infusion pumps (per site reporter) called urgent 800# on [redacted date] but the message said it was not supported on the weekends.Called global complaints line again on monday [redacted date] and left messages.No response.Was able to email our sales rep on monday and have him attend our 5pm meeting on [redacted date].He did not bring anyone from quality and could not assist in troubleshooting or giving feedback to the clinical team.He would pass along our information to the quality team.We asked for a contact so we could escalate immediately if another event occurs and have support as close to the event as possible.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 16760975
• MDR Text Key: 313494125
• Report Number: 16760975
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Lot Number: 4349146
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention