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

CARTAGO MODEL 6060 PUMP ADMINISTRATION SET SABRATEK 6060 PUMP SET   back to search results
Catalog Number 2M9859
Event Date 04/01/2003
Event Type  Other   Patient Outcome  Required Intervention;
Event Description

The parent of pt with autoimmune enteropathy stated that within 1 hour of starting an infusion of tpn solution using this set, the pt reacted with a red raised rash covering the entire body relieved by administration of 7. 5mg of benadryl iv push. The parent feels the pt is reacting to something inherent to the set, due to the fact that the pt is able to use a different brand of administration set without a reaction. The home health agency for the pt reports that if the complaint set is used with only d10%w, the pt does not react, but when used with tpn, with or without lipid, the pt reacts with hives. While the pt was hospitalized, several attempts were made to use the complaint set, but the pt reacted each time the set was used with tpn, with or without lipids. No additional info is available.

 
Manufacturer Narrative

There is one known difference between the baxter set and the set of a different brand: the baxter set is eto sterilized, the other is gamma sterilized. The set was not tested for eto residual since there will always be trace amount of this gas present. The 6060 sets have a release criterion of <2mg residual eto before release. Upon completion of a batch review, should any aberrancies be shown, a follow up report will be submitted.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameMODEL 6060 PUMP ADMINISTRATION SET
Type of DeviceSABRATEK 6060 PUMP SET
Baseline Brand NameMODEL 6060 PUMP ADMINISTRATION SET
Baseline Generic NameSABRATEK 6060 PUMP SET
Baseline Catalogue Number2M9859
Baseline Device FamilySABRATEK 6060 PUMP SET
Baseline Device 510(K) NumberK941984
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed05/01/1995
Manufacturer (Section F)
CARTAGO
600 mts.
oeste de entrada principal
cartago
COSTA RICA
Manufacturer (Section D)
CARTAGO
600 mts.
oeste de entrada principal
cartago
COSTA RICA
Manufacturer Contact
christine brown-strysik
route 120 and wilson rd
round lake , IL 60073
(847) 270 -5279
Device Event Key449756
MDR Report Key460814
Event Key436571
Report Number6000001-2003-06287
Device Sequence Number1
Product CodeFPA
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/14/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/13/2008
Device Catalogue Number2M9859
Device LOT NumberR03A13297
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/22/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2003
Is The Device Single Use? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 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