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

Model Number 10879047

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problems Exposure to Body Fluids (1745); Venipuncture (2129)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.

Event Description

When the nurse was removing the iv tubing from the pump, the tubing broke near the blue clamp.This caused the medication to spray her in the face and eyes.The medication was a blood product so she had to go through the blood product exposure process.".

Event Description

The customer reported that when the nurse was removing the iv tubing from the pump, the tubing separated near the blue safety clamp and caused blood products to leak and spray into the nurse's face and eyes.Due to the event the nurse had to go through the facility's "blood product exposure process." there was no patient harm.

Event Description

The customer reported that when the nurse was removing the iv tubing from the pump, the tubing separated near the blue safety clamp and caused ivig blood products to leak and spray into the nurse's face and eyes.Due to the event the nurse had to go through the "blood product exposure process", however, occupational health determined that no blood work or prescribed medications were necessary due to the product being sterilized.The nurse states that her left eye remains irritated and itchy and she is planning to make an eye doctor appointment.There was no patient harm.

Event Description

The customer reported that when the nurse was removing the iv tubing from the pump, the tubing separated near the blue safety clamp and caused ivig blood products to leak and spray into the nurse's face and eyes.Due to the event the nurse had to go through the "blood product exposure process", however, occupational health determined that no blood work or prescribed medications were necessary due to the product being sterilized.The nurse states that her left eye remains irritated and itchy and she is planning to make an eye doctor appointment.There was no 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
• MDR Report Key: 7656300
• MDR Text Key: 112992487
• Report Number: 9616066-2018-00948
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10879047
• Device Catalogue Number: 10879047
• Other Device ID Number: 10885403232275
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE: (B)(6) 2018
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR