|
Model Number 8637-40 |
Device Problems
Aspiration Issue (2883); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/02/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: 8709sc, lot# n312165003, implanted: (b)(6) 2012, product type: catheter.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving gablofen (2000 mcg/ml at 467 mcg/day) via an implanted pump.The indication for pump use was cerebral palsy and intractable spasticity.On (b)(6) 2018 it was reported that the patient was having a routine pump replacement procedure.During the procedure, the hcp was unable to get any flow through the catheter.The issue was diagnosed via cap (catheter access port) aspiration.The patient had not complained of any therapy issues.The catheter was replaced.Following the procedure, the new pump was delivering gablofen (2000 mcg/ml at 350 mcg/day).No further complications were reported/anticipated.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information was received and it was reported that the cause for being unable to get any flow through the catheter was undetermined.No further complications were reported/anticipated.
|
|
Search Alerts/Recalls
|
|
|