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Catalog Number 620040601SSP |
Device Problem
Insufficient Information (3190)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Increased Respiratory Rate (2486)
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Event Date 10/28/2013 |
Event Type
malfunction
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Event Description
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It was reported that the anaesthetist experienced problems during a laparoscopic cholecystectomy.Within the first two minutes, tachycardia and a fall in blood pressure was observed with low output.It was further reported that a severe hypotension out of proportion compared with the usual hypotension due to pneumoperitoneum.The company representative assumed that the patient was tied.Once the surgeon started the dissection no hemodynamic problems; very stable.The customer reports acute respiratory increase peak pressure 15mmhg, without cause, immediately afterwards co2 drop so again with acute drop in blood pressure of 130/85 to 50/35.The customer reports that this could however not be explained by a newly constructed pneumoperitoneum.'the customer reports that the surgeon was informed, no changes in intra -abdominal pressure.However, the customer reports it is inevitable that there are strong increase in intra- abdominal pressure occurred; supposedly seen big swings and blood pressure ventilation pressures clearly.The customer reports that this can be allegedly observed from the trends in the anesthesia file.
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Manufacturer Narrative
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The product was not returned for investigation.The reported failure mode could not be confirmed.Probable root causes for the reported failure could have been caused by: bad lpu/hpu, bad pressure sensors or pressure control valves , use error and/or, over due for calibration.However, this cannot be confirmed since the unit was not returned for investigation.In the event that the unit is returned, a full evaluation will be conducted and a follow up report will be issued.In sum, the product was not returned for investigation and the reported failure mode could not be confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the aneasthetist experienced problems during a laparoscopic cholecystectomy.Within the first two minutes, tachycardia and a fall in blood pressure was observed with low output.It was further reported that a severe hypotension out of proportion compared with the usual hypotension due to pneumoperitoneum.The company representative assumed that the patient was tied.Once the surgeon started the dissection, no hemodynamic problems; very stable.The customer reports acute respiratory increase peak pressure 15mmhg, without cause, immediately afterwards co2 drop, so again with acute drop in blood pressure of 130/85 to 50/35.The customer reports that this could however not be explained by a newly constructed pneumoperitoneum.'the customer reports that the surgeon was informed, no changes in intra -abdominal pressure.However, the customer reports it is inevitable that there are strong increase in intra- abdominal pressure occurred; supposedly seen big swings and blood pressure ventilation pressures clearly.The customer reports that this can be allegedly observed from the trends in the anesthesia file.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Search Alerts/Recalls
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