MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Inaccurate Delivery (2339)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)() occupation: product complaint analyst.

Event Description

Information was received indicating that a smiths medical cadd cassette reservoir being used with a cadd legacy plus pump had a "no disposable" alarm while administering 5fu.The alarm was unable to be resolved and the patient went to the clinic.The pharmacy attempted to replace the cassette, but when the bag was pulled from the cassette, only 5ml was left.The pump reflected that the reservoir was at 65ml.3840mg was in each 100ml cassette.The original programming was 100ml residual volume at a rate of 2.2ml/hr.At the time the patient went to the clinic, the residual volume read 65ml, at a rate of 2.2ml and 0ml was administered, but it was believed that the patient cleared the amount.There was no leaking, the line was primed with the prime button and equashield was used.The patient felt fine when she went to the clinic.Neulasta on pro was administered to the patient.Approximately 1 hour later, the patient began to experience stomach pain, nausea and felt hot and cold.The patient was also tachycardic- ekg was completed.The patient was sent to the hospital for hydration where she was admitted.There is no correlation of under infusion of 5 ifu chemo medication causing this event, as this occurred one hour into the infusion of neulasta with patient feeling fine prior to event.

• Brand Name: CADD CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11975664
• MDR Text Key: 255406637
• Report Number: 3012307300-2021-05853
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4060911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1