• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MINIBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION MINIBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number MZ9283
Device Problem Fluid Leak (1250)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
Event Type  Injury  
Manufacturer Narrative
The customer¿s report of a leak was confirmed. Functional testing confirmed leaking from two ports on the first quad fuse set and from one port of the second quad fuse set. Examination under magnification showed a microchannel on the interior walls of the maxzero component which allowed fluid to leak. Each maxzero port was measured and found to be within specification. The root cause of the microchannel is an equipment error during the inspection and testing process during final assembly of the maxzero component.
 
Event Description
The customer reported that the tubing leaked epinephrine around the fused cap of the set, which caused the patient to become hypotensive; then when the tubing was changed the patient became hypertensive while the set was connected to the patient's central line. The sedation was held since it was initially thought to be the cause of the hypotension however it was later determined that the hypotension was due to the lack of epinephrine caused by the leak. There was no lasting harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMINIBORE EXTENSION 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7733109
MDR Text Key115522021
Report Number9616066-2018-01191
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/15/2021
Device Model NumberMZ9283
Device Catalogue NumberMZ9283
Device Lot Number18015671
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2018
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: 07/30/2018 Patient Sequence Number: 1
-
-