Catalog Number SP0213 |
Device Problem
Crack (1135)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Date 10/12/2020 |
Event Type
Death
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Manufacturer Narrative
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Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.Linked to mfg report number: 2648988-2020-00039 and 2648988-2020-00040.
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Event Description
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This 1 of 3 of reports.A facility reported bloody cerebrospinal fluid was noted to be leaking from around the patient line stopcock when the external ventricular drain was placed into a patient with intracerebral hematoma with intraventricular extension on (b)(6) 2020.On (b)(6) 2020, on closer evaluation, there was a crack directly opposite the yellow cap.Around 10mls of csf leaked, since it was bloody it was noted fairly soon and did not result in patient harm.The drain was changed out for a new drain.Additional information has been requested.
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Manufacturer Narrative
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Additional information received indicated that the drain was in use and require replacement by the surgeon.There was no known adverse consequence as the patient passed away due to course of disease.
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Event Description
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N/a.
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Manufacturer Narrative
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A sample was received for evaluation: only the patient line was included.The stopcock was cracked on the side and bottom; also, it was observed that one of the stopcock¿s connectors was bent in an angle of approximately 45 degrees.The stopcock was placed side by side with a normal stopcock for comparison purposes and it can be concluded that the stopcock was subject to excessive force or accidentally hit or trapped against a hard surface causing the observed conditions (bent/broken).The root cause is supported by the fact that during the initial connection of the device, no anomaly was observed and after 2 days of use the stopcock damage was noticed.According to medical assessment conclusion: ¿there is not evidence to suggest that the product performance issue with the accudrain is causal to the demise of the patient.The surgeon performed successful replacement when the device defect was noted, which is the recommended course of action in this situation.¿.
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Search Alerts/Recalls
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