EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP
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Model Number T001691M |
Device Problem
Physical Resistance/Sticking (4012)
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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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As reported, during use in patients with these pressure monitoring sets with vamp with different lot numbers, the rigidity of the device caused the non-edwards arterial catheter connected to the disposable pressure transducer (dpt) with vamp to be pulled out from inside patients despite the extra fixation.Extra fixation (4 sutures instead of 2) was needed due to the device being heavy and therefore exerting pressure on the arterial line.A new peripheral arterial site was needed to insert a new catheter and connect a new dpt with vamp.Patient demographics requested.Additionally, the plunger is hard to move and the whole device is rigid and difficult to manipulate and to take blood samples.There was no allegation of patient injury in none of the cases.
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Manufacturer Narrative
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It was further informed that the devices were not available for evaluation since it were discarded at hospital.However, an engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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Manufacturer Narrative
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Updated: h6 ( type of investigation, investigation findings, investigation conclusions).Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.Based on further investigation completed by the engineers at the manufacturing site, a definitive root cause was unable to be determined.Additionally, it could be verified that there are current controls in place to prevent this type of malfunction in our manufacturing process.Edwards will continue to review and monitor all events.
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Search Alerts/Recalls
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