FDA Adverse Event Other Summary report: N

1314426-2000-00005

MDR report key: 297907 · Received September 21, 2000

Report

Report Number
1314426-2000-00005
Event Type
Other
Date Received
September 21, 2000
Date of Event
May 6, 2000
Report Date
September 21, 2000
Manufacturer
THE KENDALL COMPANY
Product Code
FOS
Report Source
Manufacturer report

Narratives

Description of Event or Problem · 1

KENDALL HEALTHCARE REC'D REPORT (INITIAL REPORT# 390081-2000-0006) FROM FACILITY, 09/18/2000, STATING THAT A PREMATURE INFANT IN INTENSIVE CARE NURSERY. HAD AN UMBILICAL ARTERIAL CATHETER AND UMBILICAL VENOUS CATHETER IN PLACE. DURING REMOVAL OF THE UBMILICAL ARTERIAL CATHETER, THE INFANT ARRESTED. FOUND TO HAVE A PERICARDIAL EFFUSION WHICH REQUIRED IMMEDIATE PERICARDIAL CENTESIS. INFANT SUCCESSFULLY RESUSCITATED. REC'D ON 09/18/2000 AS WELL FROM FACILITY REPORT# 390081-2000-0006 AN UPDATE CORRECTION: THE INFANT NOTED TO BE IN BRADYCARDIA W/CYANOSIS AS STAFF MEMBER PREPARED TO REMOVE ARTERIAL LINE. IT WAS NOT REMOVED. PROLONGED ADVANCED CARDIAC LIFE SUPPORT AND PERICARDIAL CENTESIS WAS ADMINISTERED. IT WAS LATER DETERMINED THAT THE MOST LIKELY CAUSE OF THE EVENT WAS THE UMBILICAL VENOUS LINE WAS FOUND TO BE POSITIONED AGAINST THE WALL OF THE RIGHT ATRIUM AND LEAKED HYPERALIMENTATION FLUID ACROSS THE PERICARDIUM. INFANT DEVELOPED PERICARDIAL TAMPONADE. A PORTION OF THE UMBILICAL VENOUS CATHETER LINE APPEARED AT A DIFFERENT VERTEBRAL LEVEL THAN PREVIOUSLY NOTED. STRETCHED BETWEEN T6 AND T8. SUTURE ANCHOR STILL TIGHT. HYPERALIMENTATION FLUID THOUGHT TO HAVE SOMEHOW SLOWLY CROSSED THROUGH THE WALL OF THE ATRIUM TO THE PERICARDIUM WHERE IT COLLECTED. NOT BELIEVED TO BE A RESULT OF PERFORATION. INFANT DEVELOPED ACUTE RESPIRATORY DISTRESS SYNDROME. DID RECOVER AND DISCHARGED HOME FOR OUTPATIENT F/U.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FOS THE KENDALL COMPANY UNK

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization