Model Number 2008T HEMODIALYSIS SYS., WITH CDX |
Device Problem
Pressure Problem (3012)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/23/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The plant investigation is in progress.A supplemental medwatch will be submitted upon the completion of this activity.
|
|
Event Description
|
The user facility reported that a low trans membrane pressure (tmp) alarm was generated by the 2008t hemodialysis (hd) machine while a patient underwent a routinely scheduled hd treatment.Reportedly, this resulted in blood backing up into the venous pressure transducer.The patient's estimated blood loss (ebl) was noted as being approximately 10 milliliters (ml).No patient adverse effects were experienced and no medical intervention was required as a result of this event.Following the event, the 2008t hd machine was removed from service and evaluated by the facility biomedical technician (biomed).The venous pressure calibration failed functional testing.The biomed replaced the venous internal transducer and line which resolved the issue.Functional testing performed by the biomed confirmed that the system was operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.
|
|
Manufacturer Narrative
|
The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.Follow-up provided by the biomed revealed that the unit was removed from service for evaluation following the event.The venous pressure calibration failed functional testing.The biomed replaced the venous internal transducer and line which resolved the issue.Functional testing performed by the biomed confirmed the system was operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
|
|
Search Alerts/Recalls
|