ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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Catalog Number 011-46110-29 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation, however, it is yet to be received.
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Event Description
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The event involved a transpac® iv monitoring kit w/03 ml squeeze flush device, safeset¿ reservoir, 84" red stripe arterial pressure tubing and 2 needleless valves which was reported to have leaked isotonic solution for arterial catheter during patient use.The customer reported that a line where one of the connections, normally crimped, was leaking.The customer reported a delay in therapy, about 20 min (two circuits to re-prime and reinstall).The patient¿s condition was said to be unmodified.The device was removed and reinstalled under strict aseptic conditions twice.There was no physical defect noted before use.The leak was cleaned-up as per facility protocol.There was patient involvement, however, no harm was reported as a consequence of this event.
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Manufacturer Narrative
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One used device was returned for evaluation on 8/29/23.No visual anomalies were observed on the returned set.The returned set was primed and pressure leak tested; no leaks were observed.The product performed per the specifications.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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Search Alerts/Recalls
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