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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problems Dyspnea (1816); Fever (1858); Increased Respiratory Rate (2486)

Event Date 01/16/2017

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because no product was rerceived for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that while checking a cytarabine infusion the tubing was found to be hyperextended with the blue tip of the tubing (presumed to mean the upper fitment) resting above the channel.The nurse adjusted the tubing to normal position.Shortly thereafter, it was noticed that the iv pump was wet and that there was fluid on the floor.The nurse opened the chamber door and found the tubing with a "slit" in it.At an unspecified time the patient developed new onset temperature of 101.1, new tachypnea with a respiratory rate of 32 with audible wheezing, shortness of breath and cough.Antibiotic therapy was initiated.There was no report of lasting patient harm.

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6323922
• MDR Text Key: 67182120
• Report Number: 9616066-2017-00173
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8015,8100
• Patient Outcome(s): Required Intervention