Model Number 011-46110-48 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not been received.
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Event Description
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The event occurred on an unspecified date in (b)(6) 2018.The customer reported the arterial tubing, before the three way stopcock, is detaching from the secure connector of the bifurcated monitoring kit resulting in a leak.The event occurred in the intensive therapy unit or operating theatre.The customer reported that there was minimal blood leakage as a result of the leak and the patient's blood pressure remained stable.There was no reported delay of critical therapy and no medical interventions required.There were no adverse operator consequences reported.The device was changed out with no further problems encountered.
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Manufacturer Narrative
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One (1) used partial bifurcated monitoring kit was received for testing.A separation was confirmed between the 83" pressure tubing and the male luer.The separated tubing showed signs of insufficient solvent.A same lot sample of a female luer on the opposite side of the 83" arterial tubing was pull tested and passed specification.A dhr review was completed and two (2) relevant non-conformities were noted.One non-conformity was due to four (4) pieces failing functional pull testing.The cause was attributed to insufficient solvent.Then 100% functional testing was conducted on the lot with 28 additional pieces found to be non-conforming.One other non-conformity found one piece that had a tubing separation during a movement and flexion test.Then 100% inspection was completed and 54 additional non-conformities were found.Icu medical, through continuous initiatives has initiated a multitask team and reviewed the assembly process of this subassembly.Subsequent to the initial medwatch report, manufacturing site was updated to reflect the legal manufacturing address instead of the address of the contact office.Corrected information can be found in mfr site section.
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Search Alerts/Recalls
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