• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATIONMEDSYSTEM (MS) III INFUSION PUMP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

CAREFUSION CORPORATION MEDSYSTEM (MS) III INFUSION PUMP   Back to Search Results
Model Number 2865B
Event Date 10/31/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed. (b)(4).

 
Event Description

Customer's incident report states "while on route to edmonton pump would continue to stop infusing. All lights would turn on and wouldn't turn off till tubing was removed from pump. Once turned off and powered on again would work properly for 30 mins and repeat failure. The bottom of main screen filled up with the letter "b" and on drip/infusion screen the number "1" from (indecipherable) would fill up the screens. I monitored the amount and it was infusing at 150 ml/hr accurately. Once in edmonton error code 305 displayed on monitor and pump stopped working". There was no discernible effect on the pt from the pump failure as they were able to run the infusion off the pump when the device would fail. There was no pt harm and no medical intervention was required. Drug infusing was 10% ethanol drip for methanol/ethylene glycol ingestion.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDSYSTEM (MS) III INFUSION PUMP
Manufacturer (Section F)
CAREFUSION CORPORATION
san diego CA
Manufacturer (Section D)
CAREFUSION CORPORATION
san diego CA
Manufacturer (Section G)
Manufacturer Contact
mona ledwin
10020 pacific mesa blvd.
san diego , CA 92121
(858) 617 -6477
Device Event Key2460817
MDR Report Key2403577
Event Key2300413
Report Number2016493-2011-00621
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Company Representative,Other
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 11/02/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2865B
Device Catalogue Number2865B
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer11/08/2011
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received11/02/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2007
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?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 11/23/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
UNK
-
-