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

Model Number 2426-0007

Device Problems Backflow (1064); Partial Blockage (1065); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.

Event Description

It was reported from the surgical unit that there was a hole in the iv tubing set which resulted in fluids on the ground.Blood backflow was visible in the tubing and caused significant clotting in the midline and buff cap.There was no impact to the patient.

Manufacturer Narrative

The customer¿s report there was a hole in the iv tubing set which resulted in a leak was confirmed.Functional priming testing found the set leaked from the tubing above the distal smartsite port.No other leaks were observed throughout the set.The set was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Functional testing was performed allowing fluid to flow through the whole set by gravity, the set leaked from the previously observed cut in the tubing.The source of the leak is due to a cut in the tubing.The root cause could not be determined.

Event Description

It was reported from the surgical unit that there was a hole observed in the iv tubing set which resulted in fluids leaking on the ground.Blood backflow was also visible in the tubing and caused significant clotting in the midline and buff cap.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.

Manufacturer Narrative

The customer¿s report that there was a hole in the iv tubing set which resulted in a leak was confirmed.Functional priming testing found the set leaked from the tubing above the distal smartsite port.No other leaks were observed throughout the set.The customer's report of blood backflow was not confirmed, however; the customer's experience is likely a result of the hole in the tubing.The set was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Functional testing was performed by filling a lab iv bag with blue dye water and attaching it to the set allowing fluid to flow through the whole set by gravity.The root cause of the cut damage could not be determined.

Event Description

It was reported from the surgical unit that there was a hole observed in the iv tubing set which resulted in fluids leaking on the ground.Blood backflow was also visible in the tubing and caused significant clotting in the midline and buff cap.It was further confirmed during follow up, that there was no patient harm or impact 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: 9572300
• MDR Text Key: 184673795
• Report Number: 9616066-2020-00043
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1