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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.Patient information was requested, but not provided.

Event Description

It was reported that while infusing a chemotherapy mixture of (etopiside, doxorubicin, and vincristine) infusion which had been started early in the am.The customer reported that by 3 pm to 4 pm the soft part of the tubing that is inside the pump developed a bubble (like a aneurysm on the tubing).It was large enough that it forced the door of the infusion pump to open.The bubble did burst and leaked.The nurse clamped the tubing to prevent further leakage.Although, it was reported that patient care was delayed for 2 hours it did not contribute to, or result in serious adverse impact to patient or the caregiver.

Manufacturer Narrative

Additional information provided in sections: a.3.B.7 race/ ethnicity: white.

Event Description

It was reported that while infusing a chemotherapy mixture of (etopiside, doxorubicin, and vincristine) infusion which had been started early in the am.The customer reported that by 3 pm to 4 pm the soft part of the tubing that is inside the pump developed a bubble (like a aneurysm on the tubing).It was large enough that it forced the door of the infusion pump to open.The bubble did burst and leaked.The nurse clamped the tubing to prevent further leakage.Although, it was reported that patient care was delayed for 2 hours it did not contribute to, or result in serious adverse impact to patient or the caregiver.

• 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: 9310095
• MDR Text Key: 190507516
• Report Number: 9616066-2019-03234
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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: 10/21/2019

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 Expiration Date: 10/17/2020
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 17106704
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE (B)(6) 2019