InjuryFII
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Received Jun 9, 2008
Report 2937457-2008-00006 · MDR key 1064676
Device
Generic name
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Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
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Lot number
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Product problems
- Device Alarm System
- Disconnection
- Fluid/Blood Leak
Patient
Not reported
- Therapy/non-surgical treatment/delayed/prolonged
- Treatment with medication(s)
- Hospitalization required
- Blood Loss
Narrative
Additional Manufacturer Narrative
THE DISCONNECTION MAY BE ATTRIBUTED TO USER ERROR IN NOT SECURING THE VENOUS MONITOR LINE TO THE TRANSDUCER PROTECTOR. THE CHANGE IN VENOUS PRESSURE READING MAY NOT BE DETECTED IF THE TRANSDUCER PROTECTOR HAD BECOME WETTED WITH BLOOD PRIOR TO THE DISCONNECTION.