FDA Adverse Event Other Summary report: N

ON-Q PUMP

MDR report key: 2614855 · Received June 8, 2012

Report

Report Number
MW5025756
Event Type
Other
Date Received
June 8, 2012
Report Date
March 28, 2012
Manufacturer
I-FLOW CORP.
Product Code
MEB
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

ONQ PUMP TUBING WITH LUER LOK ADAPTOR FITS LUER LOK ADAPTERS ON IV TUBING. ONQ PUMPS ARE OFTEN FILLED WITH LOCAL ANESTHETICS, POTENTIALLY FATAL IF GIVEN IV. THERE IS NO LABELING ON THE PUMP OR TUBING TO NOT ATTACH IT TO AN IV LINE. THIS EVENT DID NOT REACH A PT, BUT WAS A DESKTOP DEMONSTRATION. FROM FOLLOW-UP: DO YOU KNOW IF THE ON-Q PUMP COMES WITH TUBING ATTACHED? THE TUBING IS ATTACHED TO THE PUMP. CAN YOU SHARE WITH US WHAT TYPE OF TUBING IS IT? THE TUBING ISN'T IDENTIFIED. WE USE BOTH SINGLE LUMEN AND DOUBLE LUMEN PUMPS, AND THEY ALL END IN A LUER LOK WHICH FITS OUR IV TUBING PORTS. OUTCOME: THIS EVENT DID NOT REACH A PT, BUT WAS A DESKTOP DEMONSTRATION. WHEN AND HOW WAS ERROR DISCOVERED: DISCOVERED BY PHARMACIST (ME), BECAUSE WE WERE ASKED TO SEND A REPLACEMENT PUMP TO AN INPATIENT UNIT. MY UNDERSTANDING WAS THAT THE PUMPS AREN'T USED ON INPATIENTS, ONLY OUTPATIENTS. BUT, APPARENTLY, THEY ARE USED ON INPATIENTS. WHEN I LEARNED ABOUT THE SECOND PUMP BEING SENT TO THE NURSING UNIT, I ASKED WHO CONNECT IT, HOW WE KNEW THEY WERE COMPETENT, AND THEN DECIDED TO INVESTIGATE IF THEY COULD BE CONNECTED TO IV LINES IN ERROR. REPORTER'S RECOMMENDATIONS: I HAVE REQUESTED A MULTI-DISCIPLINARY TEAM TO DEVELOP POLICIES AND PROCEDURES RELATED TO THESE PUMPS FOR OUTPATIENTS (PERHAPS HAS IV ACCESS) AND FOR INPATIENTS. APPARENTLY THE ENTIRE 'KIT' (WE ONLY RECEIVED THE PUMP FROM OUR OPERATING ROOM FOR FILLING) HAS A 'NOT FOR IV USE STICKER', WHICH THE OPERATING ROOM PREVIOUSLY HASN'T USED, BUT WILL NOW PLACE ON THE PUMP TUBING. (B)(6) MEDICATION ERRORS REPORTING PROGRAM. (B)(6) IS A FEDERALLY CERTIFIED PT SAFETY ORGANIZATION AND AN FDA MEDWATCH PARTNER. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ON-Q PUMP PUMP MEB I-FLOW CORP.

Patients

Seq Age Sex Outcome Treatment
1