MEDFUSION 2010I SYRINGE INFUSION PUMP
Received Sep 17, 2004
Report 1036813-2004-00070 · MDR key 5322441
Device
Product problems
- Failure to Sense
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE UNIT ACCEPTED A 60CC BD SYRINGE AS A 20CC BD SYRINGE AND INFUSED AS SUCH DUE TO A NONFUNCTIONAL SIZE POTENTIOMETER. MEDEX WAS ABLE TO CONFIRM THE ISSUE AND DETERMINE A CAUSE. THIS ISSUE IS BEING MONITORED FOR TREND. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. MEDEX CONSIDERS THIS MDR CLOSED WITH THIS REPORT. MEDEX RECOGNIZES THAT THIS REPORT IS NOT BEING SUBMITTED WITHIN THE REQUIRED TIME FRAME AS OUTLINED IN THE REGULATION. THE MDR REPORTING DEADLINE BASED UPON THE DATE THE INFO WAS RECEIVED WAS 09/16/2004. MEDEX CONTINUES TO BE COMMITTED TO REGULATORY COMPLIANCE AND WILL TAKE STEPS TO ENSURE THAT THIS DOES NOT RECUR.
Description of Event or Problem
THE REPORTER STATED THAT THE PUMP WAS NOT RECOGNIZING SYRINGES. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.