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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7656300
MDR Text Key112992487
Report Number9616066-2018-00948
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
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 Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10879047
Device Catalogue Number10879047
Other Device ID Number10885403232275
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/02/2018 Patient Sequence Number: 1
Treatment
8100,8015, THERAPY DATE: (B)(6) 2018
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