Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION ALARIS SYRINGE MODULE SYRINGE SET
  • 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 CORPORATION ALARIS SYRINGE MODULE SYRINGE SET Back to Search Results
Model Number 10798703
Device Problems Fluid/Blood Leak (1250); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2014
Event Type  malfunction  
Event Description
The customer reported a chemo infusion "pulled saline from the bag into the syringe." after flushing through the chemo, the line split in half.The chemo was flushed through using the syringe pump and as a result of the split in the tubing, the set leaked.The customer also noted as soon as the syringe was attached to the set, saline from the attached bag immediately started to fill the syringe.No pt harm or medical intervention was reported.No further pt/event info was reported.
 
Manufacturer Narrative
Manufacturer's report date: 03/26/2014.Internal file no: (b)(4).The affected product has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS SYRINGE MODULE SYRINGE SET
Manufacturer (Section D)
CAREFUSION CORPORATION
san diego CA
Manufacturer Contact
michelle bitto
10020 pacific mesa blvd.
san diego, CA 92121
8586173316
MDR Report Key3851372
MDR Text Key4657804
Report Number9616066-2014-00303
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K811885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Pharmacist
Remedial Action Other
Type of Report Initial
Report Date 02/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10798703
Device Catalogue Number10798703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2014
Initial Date FDA Received03/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SYRINGE MODULE: SN UNK; ALARIS PC UNIT
-
-