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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS NON VENTED BLOOD SET SET, EXTENSION, INTRAVASCULAR

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CAREFUSION ALARIS NON VENTED BLOOD SET SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 2477-0000
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Information (3190)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
A 100ml baxter bag ndc 0338-0049-48 lot p375030 exp aug19 0. 9% sodium chloride injection and one used hemostat. Pediatric patient. (picu). An unexpected return was received from the customer without details or information of the event. Visual inspection confirmed a leak at the bottom of the silicone pump segment (p/n 12088541). The set was received with blood throughout the tubing. Functional testing identified a leak at the same location. Closer inspection under a lab microscope observed that the leak was due to a small tear on the silicone segment. No tool marks or crush marks were observed on the lower fitment near the tear. The cause of the leak was a tear in the silicone section of the tubing. The root cause of the tear was not identified.
 
Event Description
The customer reported that supply chain received a set from the picu; the failure mode with the set was not provided. Although requested, no additional information was available.
 
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Brand NameALARIS NON VENTED BLOOD SET
Type of DeviceSET, EXTENSION, 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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8695508
MDR Text Key147880403
Report Number9616066-2019-01542
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2477-0000
Device Catalogue Number2477-0000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/13/2019 Patient Sequence Number: 1
Treatment
THERAPY DATE (B)(6) 2019
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