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

Model Number 20028E

Device Problems Fluid/Blood Leak (1250); Separation Failure (2547)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Age: adult.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

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.4 mg/ml leaked during a continuous infusion with a total dose of 100 mg.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 added; g.3 & h.6.(device code).Correction; e.2, & e.3.******************************************************* the customer¿s report that leaking occurred with the filter was confirmed.The sets were visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and its components.Visual inspection of the set noted clear liquid was observed within each of the secondary sets micron adult filters and throughout the entire sets.No anomalies or evidence of damage were observed on the filters or the sets.Functional testing confirmed small droplets leaking from set 1¿s micron filter top air vent (termed ¿weeping out¿) and both of set 2¿s micron filter air vents.The root cause of the leaks were not identified.

• 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: 9687129
• MDR Text Key: 182957955
• Report Number: 9616066-2020-00398
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPIROS ADAPTER, CUROS CAP, THERAPY DATE: UNK.