FDA Adverse Event Malfunction Summary report: N

NDEHP PRIMARY PLUM CLAVE Y

MDR report key: 1660698 · Received April 14, 2010

Report

Report Number: 9615050-2010-00070
Event Type: Malfunction
Date Received: April 14, 2010
Date of Event: March 17, 2010
Report Date: March 18, 2010
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FPA
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K865060. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED A LEAK OF CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED, "PUMP ALARMED - PT RANG CALL BELL - NURSE ATTENDING NOTICED CYTOTOXIC DRUG SPILL ON THE FLOOR UNDER PUMP." AN UNSPECIFIED VOLUME OF THE SOLUTION LEAKED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. REPORTEDLY MEDICAL INTERVENTION WAS REQUIRED; HOWEVER, THE CUSTOMER CONTACT INDICATED THAT THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE INCLUDING WHAT MEDICAL INTERVENTIONS WERE REQUIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NDEHP PRIMARY PLUM CLAVE Y	UNK	FPA	HOSPIRA COSTA RICA LTD.	NA	810195H

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK