ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 147" (373 CM) BIFUSE 10 DROP BLOOD SET W/170 MICRON FILTER, HAND PUMP, 2 CLAVE®; STOPCOCK, I.V. SET
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Model Number B5216 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device is available for evaluation, however has not been received.
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Event Description
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The event involved a 147" (373 cm) bifuse 10 drop blood set w/170 micron filter, hand pump, 2 clave® w/remv 3 gang 1o2® manifold (blue, yellow, red), check valve rotating luer, 1 ext, where it was reported that air was present in line closest to the patient's central port.The patient was being transported from the operating room (or) to the intensive care unit (icu), was intubated and sedated, and receiving a blood infusion.The attending doctor noted the air in line and did not know how much air entered the patient's system.Upon closer look, it was noted that the blue port was depressed and perhaps allowed the air to enter.The issue was resolved by replacing the blood tubing.There was patient involvement, however no report of patient harm.
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Manufacturer Narrative
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The complaint of a stick down can be confirmed on the returned one used partial list #b5216, 147" (373 cm) bifuse 10 drop blood set w/170 micron filter, hand pump, 2 clave® w/remv 3 gang 1o2® manifold (blue, yellow, red), check valve rotating luer, 1 ext; lot #6037886.As received the silicone seal of the y-clave on the partial set was stuck down.The y-clave was disassembled to evaluate the seal and spike.The seal was torn on the top surface of the seal.The spike was crushed and twisted.No damages or anomalies noted on the returned new b5216.The probable cause of the damaged seal and internal spike is due to access with an incompatible mating device during use.The dfu states: "connectors are compatible with iso male luers having an internal diameter between 0.062¿ and 0.110¿." the device history review (dhr) for lot 6037886 was reviewed and no non conformities were found that would have led to the reported complaint.
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