FDA Adverse Event Other Summary report: N

INTELLIFILL I.V. DEVICE

MDR report key: 1414662 · Received July 8, 2009

Report

Report Number: 3004771245-2009-00001
Event Type: Other
Date Received: July 8, 2009
Date of Event: May 1, 2007
Report Date: July 8, 2009
Manufacturer: FOR HEALTH TECHNOLOGIES, INC.
Product Code: NEP
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS MDR IS BEING FILED RETROSPECTIVELY DUE TO AN EXAMINATION OF HISTORICAL RECORDS. AN INVESTIGATION WAS PERFORMED AND AFTER REVIEWING THE CODE AND ATTEMPTING TO REPRODUCE THIS SCENARIO, IT WAS FOUND THAT THIS SCENARIO IS UNLIKELY DUE TO THE FOLLOWING RATIONALE. THE US_EXTRET STATE CHART CONTROLS THE EXTEND/RETRACT ACTION OF THE UNLOAD STATION GRIPPERS. IF THE GRIPPERS FAIL TO REACH THEIR TARGET LOCATION, THEY ARE MOVED TO THE DEFINED "SAFE" STATE BEFORE PROVIDING THE OPTION TO RETRY TO ABORT. IF THE "SAFE" STATE CANNOT BE REACHED, ONLY THE OPTION TO ABORT IS GIVEN. WHEN THE ABORT OPTION IS USED, ALL AIR PRESSURE IS RELEASED FROM THE DEVICE PRIOR TO UNLOCKING THE DOORS TO ALLOW ENTRY. THE GRIPPERS ARE PNEUMATICALLY OPERATED AND WOULD ONLY RETRACT THEMSELVES IF AIR PRESSURE WAS PRESENT. IT IS MORE LIKELY THAT THE GRIPPERS RETRACTED DUE TO THE FORCE OF THE OPERATORS ATTEMPT TO UN-JAM THEM MANUALLY.

Description of Event or Problem · 1

OPERATOR INJURED HIS FINGER, WHEN REMOVING A SYRINGE THAT WAS STUCK AT THE OUTPUT GRIPPER. THE INJURY RESULTED IN SIX STITCHES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTELLIFILL I.V. DEVICE	PHARMACY COMPOUNDER	NEP	FOR HEALTH TECHNOLOGIES, INC.	INTELLIFILL I.V.	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other