FDA Adverse Event Malfunction Summary report: N

PRIM SYM SET 2 CL W/FILTERTEK VALVE

MDR report key: 2505135 · Received March 21, 2012

Report

Report Number: 9615050-2012-00281
Event Type: Malfunction
Date Received: March 21, 2012
Date of Event: February 28, 2012
Report Date: March 1, 2012
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE LIST NUMBER IN D4 HAS A COMMON DEVICE NAME OF 80FPA AND A 510K OF K103344. 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 A LEAK; SUBSEQUENTLY BLEED BACK WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF INTRAVENOUS IMMUNOGLOBULIN (IVIG), AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AT 2055, THE DELIVERY WAS STARTED. AT 2115, THE NURSE NOTED BLEED BACK IN THE TUBING SET AND AN UNSPECIFIED VOLUME OF SOLUTION HAD LEAKED ONTO THE PATIENT'S BED. THE CUSTOMER CONTACT INDICATED "THE TUBING WAS FOUND TO BE CRACKED AND LEAKING FROM BOTTOM BLUE PORT OF THE IV BLOOD TUBING." IT WAS REPORTED THAT THE PATIENT'S IV ACCESS SITE WAS "BLOCKED" AND A NEW PERIPHERAL IV SITE WAS STARTED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF 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
1	PRIM SYM SET 2 CL W/FILTERTEK VALVE	UNK	FRN	HOSPIRA COSTA RICA LTD.	NA	UNK5H

Patients

Seq	Age	Sex	Outcome	Treatment
1	2 YR