MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 20028E

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Age: adult.No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that leaking occurred in the medical oncology with the 0.2 filter used separately from the tubing.They were not bonded together.Etoposide o.4mg/ml leaked during a continuous infusion with a total dose of 100mg.The treatment was delayed and prolonged due to rectifying leaking filter.The patient and employee were exposed to the chemotherapy agent.The filter was changed during infusion and the patient discharged.

Event Description

It was reported that leaking occurred in the medical oncology unit with the 0.2 filter used separately from the tubing.They were not bonded together.Etoposide 0.4mg/ml leaked during a continuous infusion, with a total dose of 100mg.The treatment was delayed and prolonged due to rectifying the leaking filter.The patient and employee were exposed to the chemotherapy agent.The filter was changed during infusion and the patient discharged.Although requested, there has been no impact to patient or user response or additional event information made available to date.

Manufacturer Narrative

Additional information provided: g.3.Correction on initial report: e.2 & e.3.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9688079
• MDR Text Key: 179437349
• Report Number: 9616066-2020-00400
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: 7613203012393
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPIROS ADAPTER, CUROS CAP, THERAPY DATE: UNK.