Model Number RT380 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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A distributor in south africa reported that the tubing of four rt380 adult dual heated evaqua2 breathing circuits were found damaged before use.There was no patient involvement.
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Manufacturer Narrative
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Ps405375, ps405376, ps405415, ps405418.Device 1: lot#: 2101755702; date of manufacturing: 10-aug-2021; udi: (b)(4).Device 2: lot#: 2101486196; date of manufacturing: 28-jan-2021; udi: (b)(4).Device 3: lot#: 2101526223; date of manufacturing: 25-feb-2021; udi: (b)(4).Device 4: lot#: 2101502344; date of manufacturing: 10-feb-2021; udi: (b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
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Event Description
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A distributor reported on behalf of a healthcare facility in south africa that the tubing of four rt380 adult dual heated evaqua2 breathing circuits were found damaged before use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Section d4 and h4: device 1: lot#: 2101755702; date of manufacturing: 10-aug-2021; udi: (b)(4).Device 2: lot#: 2101486196; date of manufacturing: 28-jan-2021; udi: (b)(4).Device 3: lot#: 2101526223; date of manufacturing: 25-feb-2021; udi: (b)(4).Device 4: lot#: 2101502344; date of manufacturing: 10-feb-2021; udi: (b)(4).Corrected data: section b5.A distributor reported on behalf of a healthcare facility in south africa that the tubing of four rt380 adult dual heated evaqua2 breathing circuits were found damaged before use.Section e1.Name and address: (b)(6).Method: the complaint rt380 adult dual heated evaqua2 breathing circuits were received at fisher & paykel healthcare (f&p) in new zealand for evaluation, where they were visually inspected and analysed.Results: visual inspection of the returned rt380 adult dual heated evaqua2 breathing circuits revealed that the tubing were found degraded.Further analysis of the subject rt380 circuits using fourier-transform infrared spectroscopy (ftir) revealed that results were consistent with uv exposure causing material degradation.Conclusion: we are unable to determine the cause of the reported event.However, it is likely that the reported event occurred due to the tube being exposed to excessive uv light for a longer period of time.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production and those that fail are rejected.The subject circuits would have met the required specifications at the time of production.The user instructions that accompany the rt380 breathing circuit state: - "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." - "do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure." -"perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
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Search Alerts/Recalls
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