FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

B. BRAUN MEDICAL, INC. HORIZON NXT INFUSION PUMP   back to search results
Model Number 610
Event Date 03/01/2004
Event Type  Other   Patient Outcome  Required Intervention;
Event Description

A field service representative for the manufacturer was notified of an over-infusion incident during a preventive maintenance visit. The pump was reportedly programmed to deliver 1000 ml at a rate of 40 ml/hr, but was found to have infused 1000 ml in 12 hours. No pt injury occurred. No further details concerning the drug infused or pt information were made available.

 
Manufacturer Narrative

Although the device was not returned to the manufacturer for evaluation, the pump was evaluated on-site by the field service representative. No functional or component fault was detected during the evaluation. The operation log for this pump was also captured and reviewed. The log clearly shows that, after 3 hours of infusing at 40 ml/hr, the rate was increased to 440 ml/hr. The pump delivered at the increased rate for over an hour, at which time the rate was again changed to 40 ml/hr. When the infusion was stopped, the total volume infused was 955. 3 ml over 12 hours and 47 minutes. The device delivered as programmed.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameHORIZON NXT
Type of DeviceINFUSION PUMP
Baseline Brand NameHORIZON NXT MODULAR INFUSION SYSTEM
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number610
Baseline Device FamilyHORIZON / HORIZON NXT MODULAR INFUSION SYSTEM
Baseline Device 510(K) NumberK913661
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed06/01/1992
Manufacturer (Section F)
B. BRAUN MEDICAL, INC.
1601 wallace dr., suite 150
carrollton TX 75006 6690
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
1601 wallace dr., suite 150
carrollton TX 75006 6690
Manufacturer Contact
ruth kummerlen quality manager
1601 wallace dr.
suite 150
carrollton , TX 75006
(972) 245 -2243
Device Event Key504742
MDR Report Key515734
Event Key489318
Report Number1641965-2004-00003
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/04/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number610
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1995
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Reuse

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH