LS LF PRIMARY IV SET 120IN CONV 0.2MIC

Report

Report Number: 9613251-2013-00129
Event Type: Malfunction
Date Received: May 3, 2013
Date of Event: April 3, 2013
Report Date: April 3, 2013
Manufacturer: HOSPIRA LTD.
Product Code: FPA
PMA / PMN Number: K101677
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE 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

UPON FURTHER QUERY, THE FOLLOWING INFORMATION WAS PROVIDED THAT INDICATED A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE. AT AN UNSPECIFIED TIME, THE CUSTOMER CONTACT REPORTED THAT THE PHLEBOTOMIST NOTED A LEAK AT AN UNSPECIFIED LOCATION OF THE TUBING SET. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE ENTERED THE PATIENT'S ROOM AND FOUND A LEAK OF AN UNSPECIFIED VOLUME OF SOLUTION AT THE LEG OF AN UNSPECIFIED CLAVE Y-SITE AND AN UNSPECIFIED AMOUNT OF BLEEDBACK. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THAT A 1/2 TO 1 INCH SEGMENTS OF AIR WAS NOTED IN THE TUBING DISTAL TO THE CLAVE Y-SITE. NO AIR WAS DELIVERED TO THE PATIENT. THE DELIVERY WAS STOPPED. AT THIS TIME, IT WAS REPORTED THAT WHILE THE NURSE WAS INSPECTING THE LEAK OF THE TUBING SET, THE TUBING SEPARATED FROM AN UNSPECIFIED CLAVE Y-SITE OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
195084	LS LF PRIMARY IV SET 120IN CONV 0.2MIC	80FPA	FPA	HOSPIRA LTD.	NA	220954W

Patients

Seq	Age	Sex	Outcome	Treatment
1