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: BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC
  • 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
 

BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C1071KJP
Device Problem Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
It was reported that an infusor device underinfused.The device was filled with 96ml of non-baxter cefepime.It was reported that the device was not empty at the end of the expected infusion time.There was approximately 10ml of solution left inside the device.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
bldg 3
irvine CA 92614
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
bldg 3
irvine CA 92614
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4376422
MDR Text Key5239880
Report Number1416980-2014-48241
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K062457
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/02/2014
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 Other
Device Catalogue Number2C1071KJP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2014
Initial Date FDA Received12/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
CEFEPIME
-
-