Model Number PXVJ0441 |
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 10/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 a part of the monthly review.
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Event Description
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It was reported a pressure tubing on a vamp was leaking and an error message was displayed on the monitor.While tubing was connected to patient umbilical art line, the error message of art line disconnected was displayed.Staff checked all connections and found vamp leakage on side of patient.Leakage was not located on the luer lock side.Per follow up with customer, uac fluid, a mixture of 50 ml sterile water with 2.5 meq sodium acetate and 25 units heparin, leaked from the tubing.It was connected to a non edwards pump.No patient injury reported.
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Manufacturer Narrative
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The reported event of leaking was confirmed.As received, adhesive tape with note of leaking was noticed on zero stopcock and tubing female connector connection.Leakage was observed at the bond joint between pressure tubing female connector of vamp jr system during leak test.Red dye solution was manually injected into vamp system to trace leak path.Leakage was found occurring across tubing bond area.No other visible leakage or damage was noticed from the returned unit.Further evaluation regarding related quality issues is under investigation.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 a part of the monthly review.
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Manufacturer Narrative
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Engineering evaluation was completed and concluded that a product risk assessment escalation was needed.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.
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Search Alerts/Recalls
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