Catalog Number SP0090 |
Device Problems
Crack (1135); Material Fragmentation (1261)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Date 01/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number: 2648988-2019-00034 and 2648988-2019-00035.
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Event Description
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This is 1 of 3 reports.A customer reported that the sp0090 special evd 10-110 w/o y site snapped off and cracked at connection.Additional information received on 26apr2019 indicated that the incident happened on (b)(6) 2019 to a (b)(6) female patient during care in the intensive care unit (icu).A cerebrospinal fluid (csf) was leaking from the ventriculostomy drainage tubing.The drops noted from tubing just proximal to manifold stopcock.Additional information has been requested.
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Event Description
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N/a.
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Manufacturer Narrative
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An additional information was received on 30may2019, that the estimated amount of csf leakage was 5 to 10ml with no adverse consequence to the patient.The drainage system was changed after the problem occurred.One bag with three (3) monitorr sp0090 devices and three (3) transducer were received.One (1) unit was of lot 3116455 and two (2) of lot 3176375;all three (3) devices were broken at the stopcock.The broken part of each stopcock was still attached to the transducers included in the package.The device history record was reviewed and no anomaly was reported during the manufacturing and packaging processes that can be associated to the reported condition.The complaint was confirmed.The most probable root cause has been identified to be related to the stopcock supplier.(b)(4).
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Search Alerts/Recalls
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