PLUNGER HOLDER/TRACK II
Received Dec 9, 2004 · Event occurred Nov 9, 2004
Report 1036813-2004-00092 · MDR key 798280
Device
Generic name
Plunger Holder/track Ii
Manufacturer
MedexModel number
PLUNGER HOLDER/TRACatalog number
NA
Lot number
NA
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DURING IN-HOUSE TESTING, THE HEX VALUE WAS NOT GREATER THAN C0 ON A PLUNGER HOLDER/TRACK II, WHICH WOULD HAVE CAUSED THE SYRINGE PUMP TO FAIL TO ALERT "LOAD SYRINGE PLUNGER" OR "OCCLUSION' DEPENDING ON THE PUMP'S SOFTWARE.
Additional Manufacturer Narrative
DURING IN-HOUSE TESTING, THE HEX VALUE WAS NOT GREATER THAN C0 ON THE TRACK, WHICH WOULD HAVE CAUSED A SYRINGE PUMP TO FAIL TO ALERT "LOAD SYRINGE PLUNGER" OR "OCCLUSION" DEPENDING ON THE PUMP'S SOFTWARE. THIS WAS DUE TO A NONFUNCTIONAL DOME SWITCH ON THE LONG FLEX CABLE. MEDEX WAS ABLE TO CONFIRM THE ISSUE AND DETERMINE A CAUSE. THE PLUNGER HOLDER/TRACK II WAS REPAIRED AND RETURNED TO THE CUSTOMER. NO ADD'L ACTION IS NECESSARY AT THIS TIME. MEDEX CONSIDERS THIS MDR CLOSED WITH THIS REPORT.