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 CORP ALARIS PUMP MODULE ADMINISTRATION SET; IV INFUSION 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 CORP ALARIS PUMP MODULE ADMINISTRATION SET; IV INFUSION SET Back to Search Results
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Overdose (1988)
Event Date 05/13/2014
Event Type  malfunction  
Event Description
The customer reported a secondary of zosyn 37.5 gram/50ml infused faster than expected.The medication was to infuse over 30 minutes, however, the bag emptied in less than 5 minutes.There was no patient harm or medical intervention.No additional patient or event details were provided by the customer.Manufacturer's report number: 9616066-2014-00508.Manufacturer's report date: 05/30/2014.(b)(4).
 
Manufacturer Narrative
(b)(4).Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the affected product be received for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
IV INFUSION SET
Manufacturer (Section D)
CAREFUSION CORP
san diego CA
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121
8586176477
MDR Report Key3879416
MDR Text Key4459937
Report Number9616066-2014-00508
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/13/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/13/2014
Initial Date FDA Received05/30/2014
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
PCA MODULS, SN UNK; ALARIS PUMP MODULE, SN UNK; SECONDARY ADMINISTRATION SET; MODEL AND LOT UNK; MANUFACTURER, MODEL AND LOT UNK; PCA ADMINISTRATION SET AND SYRINGE; MANUFACTURER, MODEL AND LOT UNK; ALARIS PUMP MODULE ADMINISTRATION SET; ALARIS PC UNIT, SN 14050008
-
-