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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products-100ml baxter bag, lot: us004093, exp: oct20, 0.9% sodium chloride injection.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that the iv tubing set leaked during the final infusion of ceftriaxone, total bag was 150ml.At the completion of the infusion there was a small puddle next to the patient and it was discovered that there was a hole in the tubing set.The patient received reduced dosage of medication, but was not impacted.

Manufacturer Narrative

Additional information added: section; b.5.(patient/event information clarified/detailed), d.11, and h.6.(device code).The customer¿s report that the tubing set leaked was confirmed based on visual inspection.There was a protrusion along the tubing above the bottom smartsite valve component marked between tape strips.There was a hole along the protrusion.Functional testing performed observed fluid to leak from the hole.The cause of the leak was due to the damaged tubing.Two tape strips were affixed along the tubing between the lower fitment and bottom smartsite valve components.The set sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.Although damage was observed, the set was reprimed.Fluid leaked from the hole.No other leak or issue was observed.The cause of the leak was due to a damaged tubing.The root cause of the damage was not identified.

Event Description

It was reported that the iv tubing set leaked during the final infusion of ceftriaxone, total bag was 150ml.At the completion of the infusion there was a small puddle next to the patient and it was discovered that there was a hole in the tubing set.Although it was noted that the patient received reduced dosage of medication, it was also 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, ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9769339
• MDR Text Key: 189230829
• Report Number: 9616066-2020-00612
• 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: 02/06/2020

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: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, 8100; THERAPY DATE (B)(6) 2020