Model Number 0998-00-3013-45 |
Device Problem
Device Displays Incorrect Message (2591)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/03/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp and was unable to find blood inside the unit.The fse determined that it was a false alarm due to a leak at the exhaust end.The iabp was returned to the customer and cleared for clinical use.Full event site name: (b)(4).
|
|
Event Description
|
It was reported that while in use on a patient the cs100 intra-aortic balloon pump (iabp) "blood detected".The nurse immediately checked the balloon and extension tube and found no blood.It is unknown if there was harm or injury to patient; however no adverse event was reported.
|
|
Manufacturer Narrative
|
Please refer to the following complete result evaluation of the getinge field service engineer (fse): a getinge field service engineer (fse) evaluated the iabp and was unable to find blood inside the iabp unit.The fse determined that it was a false alarm due to a leak at the exhaust end in blood detect tube.To fix the leak issue, the fse reconnected the filling tube between the safety disk and the fill manifold.The iabp was then returned to the customer and cleared for clinical use.
|
|
Event Description
|
It was reported that while in use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed "blood detected".The nurse immediately checked the balloon and extension tube and found no blood.There was no harm or injury to patient and no adverse event was reported.
|
|
Manufacturer Narrative
|
Additional information (investigation finalized) on 02/03/2020.Updated fields: b4, d4 (version # & udi), e1(site country), g3, g6, g7, h2, h6 (type of investigation), h10, h11.Corrected fields: d1, h6 (health effect ¿ clinical & impact).
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|