FDA Adverse Event Malfunction Summary report: N

SYMBIQ

MDR report key: 2854613 · Received October 3, 2012

Report

Report Number
2854613
Event Type
Malfunction
Date Received
October 3, 2012
Date of Event
September 21, 2012
Report Date
October 3, 2012
Manufacturer
HOSPIRA
Product Code
FPK
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MD, US

Narratives

Description of Event or Problem · 1

PATIENT PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE APPEARED TO BE LEAKING. RN ASSESSED DRESSING AND TUBING AND NOTICED FLUID LEAKING OUT OF ACTUAL TUBING NEAR THE HUB CLOSEST TO THE PATIENT. BLOOD BACKED UP FROM THE PATIENT PICC LINE INTO IV TUBING CAUSING THE PICC TO BECOME CLOTTED. RN REMOVED DEFECTIVE TUBING AND DE-CLOTTED PICC. WE HAVE SEVERAL EVENTS WITH THIS DEVICE OVER A SHORT PERIOD OF TIME AT OUR FACILITY.THERE ARE ISSUES AT 3 DIFFERENT POINTS OF CONNECTION REPORTED REGARDING THE HOSPIRA TUBING: 1. WHEN THE PRIMARY IV TUBING (PRIMARY SYMBIQ SET LIST NO. 16068-28) IS CONNECTED TO THE J-LOOP. WE HAVE 2 J-LOOP/EXTENSION SETS IN USE, IT IS UNKNOWN WHICH WAS BEING UTILIZED IN THE REPORTED INCIDENT (7" APPROX 0.73ML PRESSURE INFUSION (10ML/SEC EXT SET WITH MICROCLAVE CLEAR PURPLE CLAMP ROTATING LUER 12514-01 OR 7" APPROX 0.30ML SMALL BORE PRESSURE INFUSION (400PSIG) EXT SET WITH MICROCLAVE CLEAR PURPLE CLAMP ROTATING LUER Z3434.2. WHEN PRIMARY IV TUBING (PRIMARY SYMBIQ SET LIST NO. 16068-28) IS CONNECTED TO THE BLUE PORT (CLAVE) OF ANOTHER PRIMARY SET (PRIMARY SYMBIQ SET LIST NO. 16068-28).3. AT THE POINT OF CONNECTION OF THE SECONDARY TUBING (SECONDARY SET 34 INCH, NON-DEHP WITH INFUSION STAND HANGER LIST NO. 14230-28) AND BLUE PORT (CLAVE) OF PRIMARY TUBING (PRIMARY SYMBIQ SET LIST NO. 16068-28) ABOVE THE LEVEL OF THE HOSPIRA SYMBIQ PUMP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYMBIQ TUBING, FLUID DELIVERY FPK HOSPIRA * *

Patients

Seq Age Sex Outcome Treatment
1 85 YR