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

Model Number PRI TUBING

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Patient information requested but not provided.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that during infusion of chemotherapy, the tubing set leaked approximately 50ml of unspecified chemotherapy medication.There was a ninety (90) minutes delay in care since it included the need to contact the physician and the pharmacy.Patient was able to discharge on the day planned.There was no harm to patient.

Manufacturer Narrative

A photo of the set inside a chemo biohazard bag was provided by the customer.No leaks or issues were observed.The root cause of this failure was not identified.

Event Description

It was reported that during an infusion of chemotherapy, the tubing set leaked approximately 50ml of an unspecified chemotherapy medication.There was a ninety (90) minute delay in care, since it included the need to contact the physician and the pharmacy.Patient was able to be discharged on the day planned.It was further confirmed that there was no harm or impact to the patient as a result of this event.

• 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: 9526538
• MDR Text Key: 191110770
• Report Number: 9616066-2019-03751
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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 Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1