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

Model Number 11171447

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

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.Not hispanic/latino.

Event Description

The customer reported that the patient was receiving an unspecified antibiotic, upon completion of the infusion, the nurse remove the tubing from device when the tubing separated at the safety clamp causing normal saline to leak on the floor.It was reported that the set was in use for 30 min.When the event occurred.There was no report of patient harm.The event occurred in the cancer center.Received a copy of the customer's medwatch report from fda which states, ¿patient was receiving an antibiotic infusion.Upon completion of infusion nurse went to remove tubing from pump and tubing became disconnected where the foot clamp fits into the pump, releasing the primary bag of normal saline all over the floor.This didn't directly effect the patient because the infusion was complete.However, if the bag had contained chemotherapy or other toxic agent it could have posed a serious safety risk to staff, patient, and visitors.This is our departments 4th incidence with tubing becoming detached".An incomplete date of event of (b)(6) 2018 was provided.

Event Description

The customer reported that the patient was receiving an unspecified antibiotic, upon completion of the infusion, the nurse remove the tubing from device when the tubing separated at the safety clamp causing normal saline to leak on the floor.It was reported that the set was in use for 30 min.When the event occurred.There was no report of patient harm.The event occurred in the cancer center.Received a copy of the customer's medwatch report from fda which states, ¿patient was receiving an antibiotic infusion.Upon completion of infusion nurse went to remove tubing from pump and tubing became disconnected where the foot clamp fits into the pump, releasing the primary bag of normal saline all over the floor.This didn't directly effect the patient because the infusion was complete.However, if the bag had contained chemotherapy or other toxic agent it could have posed a serious safety risk to staff, patient, and visitors.This is our departments 4th incidence with tubing becoming detached." an incomplete date of event of (b)(6) 2018 was provided.

Manufacturer Narrative

The customer¿s complaint of tubing separated and leaked was confirmed.During visual inspection, it was noted immediately that nitro tubing was completely separated from the lower fitment.Fluid was leaking from the separation of the used set.Dimensional analysis was within specification.The root cause of the customer¿s report was identified as insufficient solvent applied at the engagement of the tubing and lower fitment during the manufacturing process.

• 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: 8204524
• MDR Text Key: 131716098
• Report Number: 9616066-2018-02625
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021234
• UDI-Public: 7613203021234
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• 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: 10/16/2021
• Device Model Number: 11171447
• Device Catalogue Number: 11171447
• Device Lot Number: 18106260
• 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: 8100,8015, TD (B)(6) 2018
• Patient Age: 74 YR