MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number 10016073

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Complaint file: not hispanic/latino, chemotherapy patient.

Event Description

The customer reported that the secondary tubing separated and leaked at the bottom of the drip chamber when opening the roller clamp to initiate a mannitol infusion.A primary maintenance fluid of normal saline was attached to the secondary set.The secondary set was newly out of the package when the event occurred.There was no patient or user harm reported.The event occurred in the cancer center.Received a copy of the customer's additional information request letter from fda which states, ¿secondary tubing set was used to prepare a bag of mannitol for administration to patient.The nurse inserted the spike into the bag of mannitol.When she went to open the roller clamp the tubing became detached from the bottom of the drip chamber and the medication went all over the nurse and the floor.The patient was not harmed in any way.The patient was later to receive dose of chemotherapy.If this had been attached to a bag of chemotherapy or other toxic agent there could have been significant risk to staff, patient, and visitors.This is the third occurrence this year with secondary tubing coming undone from the drip chamber in our department"."infuse mannitol as pre medication for chemotherapy".

Manufacturer Narrative

The customer¿s complaint of secondary set separated at drip chamber and leaked was confirmed.During visual inspection, it was noted that the pvc tubing was separated from the drip chamber outlet port.Fluid was leaking from the separation.Microscopic inspection observed no solvent applied to either side of the engagement during the manufacturing process.Dimensional analysis of the tubing was within iso-specification.The root cause of the customer¿s report was identified as a manufacturing issue due to no solvent being applied at the junction of the pvc tubing during the manufacturing process.

Event Description

It was reported that the secondary tubing separated and leaked at the bottom of the drip chamber when opening the roller clamp to initiate a mannitol infusion.A primary maintenance fluid of normal saline was attached to the secondary set.The secondary set was newly out of the package when the event occurred.There was no patient or user harm reported.The event occurred in the cancer center.Subsequently, a customer medwatch report was received from the fda which states: ¿secondary tubing set was used to prepare a bag of mannitol for administration to patient.The nurse inserted the spike into the bag of mannitol.When she went to open the roller clamp the tubing became detached from the bottom of the drip chamber and the medication went all over the nurse and the floor.The patient was not harmed in any way.The patient was later to receive dose of chemotherapy.If this had been attached to a bag of chemotherapy or other toxic agent there could have been significant risk to staff, patient, and visitors.This is the third occurrence this year with secondary tubing coming undone from the drip chamber in our department." intended procedure: "infuse mannitol as pre medication for chemotherapy".

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8204628
• MDR Text Key: 131715934
• Report Number: 9616066-2018-02626
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230110
• UDI-Public: 10885403230110
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Model Number: 10016073
• Device Catalogue Number: 10016073
• Device Lot Number: 18095220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,PRI TUBING,8100, TD (B)(6) 2018
• Patient Age: 36 YR
• Patient Weight: 96