FDA Adverse Event Malfunction Summary report: N

PRIM SYM SET 2 CL

MDR report key: 2915274 · Received January 9, 2013

Report

Report Number: 9615050-2013-00058
Event Type: Malfunction
Date Received: January 9, 2013
Date of Event: December 1, 2012
Report Date: December 19, 2012
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
PMA / PMN Number: K110901
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM AN UNSPECIFIED LOT WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. ON AN UNSPECIFIED DATE, THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AND UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE NOTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY RESUMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
11719	PRIM SYM SET 2 CL	80FPA	FRN	HOSPIRA COSTA RICA LTD.	NA	UNK5H

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			UNSPECIFIED SECONDARY TUBING SET,\| UNSPECIFIED SYMBIQ PUMP, LIST # UNK, SN UNK\| LIST # UNK, LOT # UNK