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Model Number 8637-40 |
Device Problems
Filling Problem (1233); Component or Accessory Incompatibility (2897)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving bupivacaine 35 mg/day at 50mg/ml and clonidine 140 mcg/day at 200 mcg/ml via an implantable pump for an unknown indication for use.It was reported that there was a pump alarm.The date of the elective replacement indicator (eri) was (b)(6) 2020.There were no environmental/external/patient factors that may have led or contributed to the issue.The pump was replaced.The event was resolved.The patient's status was alive - no injury.Additional information was received from a foreign hcp via a manufacturer representative.It was reported that there was no alarm.The problem was that filling the pump became more and more difficult after each emptying of the reservoir.The doctor described a presence of a big pressure during filling.For this reason, the doctor decided to replace the pump.The patient did not experience any specific symptoms because the patient did not have opioids in his pump.The pump would be returned to the device manufacturer.Information regarding the patient¿s age, weight, medical history, and other medications was unavailable.Information regarding the implant date of the pump was unavailable.
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Manufacturer Narrative
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The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.Analysis had difficulty accessing the drug reservoir prior to decontamination.Destructive analysis identified residue in the drug flow path.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.It was reported that a 0,7mm diameter needle was used to fill the pump.The refill kit was not from the device manufacturer.No diagnostics were performed to determine the cause of the issue.It was noted that the hcp experienced progressively increasing resistance to injection into the reservoir of the pump, which developed over a period of 3 refill procedures with an interval of 2 months between refills.At the end, it was impossible to inject despite having reduced the syringe volume from 20 to 5 cc, thereby allowing for markedly increased piston pressure generated.
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Search Alerts/Recalls
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