FDA Adverse Event Summary report: N

SIMS/DELTEC

MDR report key: 255480 · Received December 14, 1999

Report

Report Number
MW1017763
Date Received
December 14, 1999
Date of Event
November 1, 1999
Report Date
December 13, 1999
Manufacturer
SIMS DELTEC, INC.
Product Code
FPA
Report Source
Voluntary report
Reporter Location
UT, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE SIMS/DELTEC AJ2304 I.V. TUBING SET WITH A 0.22 MICRO-METER FILTER, AND THE MEDEX INC FS-116 TUBING SET WITH A 0.22 MICRO-METER FILTER, ARE OCCLUDING DURING INFUSIONS OF TPN IN NEWBORN INTENSIVE CARE UNIT. WHEN USING THE ABBOTT IVEX-HP FILTER SET NO. 4524 0.22 MICRO-METER, THERE ARE NO OCCLUSION PROBLEMS. THIS FILTER WAS TESTED BY PUMPING 300ML OF TPN THROUGH IT. THERE WAS NO INCREASE OF PRESSURE MEASURED AT THE INPUT OF THE FILTER WHILE PUMPING AT 10ML/HR. SEE SECTION 6 BELOW FOR TESTING OF THE SIMS/DELTEC AJ2304 I.V. TUBING SET, AND THE MEDEX INC. FS-116 TUBING SET. TEST 13. TESTED THE MEDEX INC. FS-116 TUBING SET WITH 0.22 MICRO-METER FILTER, LOT #26F202042 WITH HYPERALIMENTATION (TPN) SOLUTION THAT WAS PREPARED BY PHARMACY. THIS IS THE SAME SOLUTION TYPE USED FOR BABY. PUMPED AT A RATE OF 10ML/HR USING A 60ML SYRINGE. LOC: IVC, ORDER VOLUME: 197ML, COMPOUND VOLUME: 247 ML, TROPHAMINE 2.00GM/KG, DEXTROSE 16.000%, INTRALIPIDS 20% PB 1.50GM/KG, SOLUTION INTENDED FOR USE WITH PIGGYBACK OF INTRALIPIDS 20% PB 11.6 ML, ADDITIVES: CALCIUM GLUCONATE 2.00MEQ/KG, POTASSIUM PHOSPHATE 2.00 MMOL/KG, POTASSIUM CHLORIDE 2.00 MEQ/KG, MAGNESIUM SULFATE 0.30 MEQ/KG, CERNEVIT 0.80 ML/KG, VITAMIN K NEONATAL 80.00 MCG, NEO-TRACE ELEMENTS 1.00 ML/KG, CYSTEINE HCL 1.00 MMOL/KG, HEPARIN 1.00 UNIT/ML, FINAL SOLUTION OSMOLARITY: 1076 MOSM/1. 197ML AT 8.2ML/HR WILL RUN FOR 24:00 HOURS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SIMS/DELTEC TUBING SET WITH FILTER FPA SIMS DELTEC, INC. * 20040528

Patients

Seq Age Sex Outcome Treatment
1 *