Model Number 0684-00-0480-02 |
Device Problems
Leak/Splash (1354); Pressure Problem (3012)
|
Patient Problems
Emotional Changes (1831); Low Blood Pressure/ Hypotension (1914)
|
Event Date 03/03/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).Device not returned.
|
|
Event Description
|
It was reported that during intra-aortic balloon(iab) therapy, the console alarmed high pressure alarm and shut off.Blood quickly filled helium tubing.Patients pressures dropped, became symptomatic, pale, anxious, dizzy.Cv code called.Cv code team threaded new iabp into axillary site, removed old iabp.Old iabp had broken wire and blood in helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
|
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id#: (b)(4).H3 other text: device not returned.
|
|
Event Description
|
It was reported that during intra-aortic balloon(iab) therapy, the console alarmed high pressure alarm and shut off.Blood quickly filled helium tubing.Patients pressures dropped, became symptomatic, pale, anxious, dizzy.Cv code called.Cv code team threaded new iabp into axillary site, removed old iabp.Old iabp had broken wire and blood in helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
|
|
Event Description
|
It was reported that during intra-aortic balloon(iab) therapy, the console alarmed high pressure alarm and shut off.Blood quickly filled helium tubing.Patients pressures dropped, became symptomatic, pale, anxious, dizzy.Cv code called.Cv code team threaded new iabp into axillary site, removed old iabp.Old iabp had broken wire and blood in helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
|
|
Manufacturer Narrative
|
Device available for eval? updated from yes to no.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint #: (b)(4).H3 other text : device not returned.
|
|
Event Description
|
It was reported that during intra-aortic balloon(iab) therapy, the console alarmed high pressure alarm and shut off.Blood quickly filled helium tubing.Patients pressures dropped, became symptomatic, pale, anxious, dizzy.Cv code called.Cv code team threaded new iabp into axillary site, removed old iabp.Old iabp had broken wire and blood in helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
|
|
Manufacturer Narrative
|
Additional initial reporter: randy green, cmrp assistant manager ¿ quality assurance.Additional email address: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
|
|
Search Alerts/Recalls
|