UMBILICAL CATHETER

Additional Manufacturer Narrative

FROM THE DESCRIPTION, THIS UMBILICAL CATHETER WAS NOT INSERTED IN CORRECT POSITION, THEREFORE THIS SERIOUS ADVERSE EVENT IS NOT LINKED TO THE QUALITY OF OUR DEVICE. THE PERICARDIAL EFFUSION IS CHARACTERISTICS OF A MALPOSITION. THESE COMPLICATIONS ARE ASSOCIATED WITH THE PLACEMENT OF UMBILICAL CATHETERS . FOR INFORMATION, ALL UMBILICAL CATHETERS ARE CONTROLLED , INCLUDING 100% TESTS CARRIED OUT ON EACH CATHETER DURING THE MANUFACTURING PROCESS. THESE TESTS ARE AS FOLLOWS: THE BLUNTNESS OF THE CATHETER TIP , MARKING THE CATHETERS AND TIGHTNESS. OUR DEVICES ARE COMPLIANT TO NORM ISO 10555-1. IN THE IFU THERE CAUTIONS AS FOLLOWS: CONTROL OF POSITIONING : ALWAYS CHECK THE LOCATION OF THE CATHETER BY RADIOGRAPHY FOR UMBILICAL ARTERIAL CATHETERIZATION, THE CATHETER CAN BE SITED EITHER IN THE HIGH POSITION BETWEEN THORACIC VERTEBRAE T6 AND T9 OR THE LOW POSITION AT L3 TO L5 LEVEL THOUGH THE HIGHER POSITION IS ASSOCIATED WITH LOWER COMPLICATION RATES. FROM OUR HISTORICAL ANALYSIS OF COMPLAINTS, THERE IS NO COMPLAINT AND NO ADVERSE EVENT OF THIS BATCH. THE INVOLVED SAMPLE HAS BEEN KEPT. WE ARE WAITING FOR IT FOR INVESTIGATION.

Description of Event or Problem

PRETERM OF 24 WEEKS +3, WEIGHT 665 GR. UMBILICAL CATHETER INSERTED ON (B)(6) AT 7:00 AM, IN PLACE ON X-RAY, IN CENTRAL AT MARK 6, EFFECTIVE FIXATION, CHILD INTUBATED. DURING THE NIGHT, ON (B)(6) AT 4.50 AM, FIRST DETERIORATION IN THE CLINICAL CONDITION OF THE NEWBORN: CARDIAC MASSAGE WITH INJECTION OF 2 DOSES OF ADRENALINE (APPROXIMATELY 2.2ML WITH PRIMING), EXPOSURE TO LARYNGOSCOPE, EFFECTIVE INTUBATION BUT DECISION TO CHANGE THE INTUBATION TUBE ON THE ASSUMPTION IT WAS BLOCKED. 2ND EPISODE OF PROGRESSIVE BRADYCARDIA AT 5:40 AM WITH HR AT 100BPM/MIN AND PERICARDIAL EFFUSION WITH WEAK CONTRACTILITY. UMBILICAL CATHETER PULLED 1CM. THIS EVENT SEEMS TO BE MAINLY A PROBLEM WITH THE POSITION OF THE CATHETER. 48 HOURS AFTER THIS EVENT, THE BABY STAYS QUITE UNSTABLE DUE TO HIS IMMATURITY. THE POST EFFUSION BIOLOGICAL TESTS BECAME NORMAL AND THE FIRST TRANS FONTANELLAR ULTRASOUND TOO.