Model Number 8637-20 |
Device Problems
Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978); Unintended Movement (3026)
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Patient Problems
Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271); Underdose (2542)
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Event Date 07/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2004, product type: catheter.
Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 28-jul-2006, udi#: (b)(4).
Initial reporter occupation: non-healthcare professional.
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 consumer and a company representative regarding a patient receiving morphine (25 mg/ml at 3mg/day) via an implanted pump.
The indication for pump use was non-malignant pain/other non-malignant pain.
It was reported that the patient began having withdrawal on (b)(6) 2018.
The patient was being taken to surgery on monday ((b)(6) 2018).
On (b)(6) 2018 the patient reported that they found out that the ¿tube was crossed¿ and because of this, he was not getting the correct dose of morphine.
Per the patient, it had taken 5-6 days to figure out what was wrong, but the neurosurgeon fixed it.
No further complications were reported/anticipated.
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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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Manufacturer Narrative
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Product id 8709, serial# (b)(4), implanted: (b)(6)2004.
Product type catheter.
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 manufacturer's representative (rep).
It was reported that the patient may be a twiddler.
No further complications were anticipated/reported.
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Event Description
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Additional information was received from the consumer indicated that the catheters had crossed again on (b)(6) 2018.
It was reported that the pump had been moving.
No further complications have been reported as a result of this event.
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Manufacturer Narrative
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Concomitant medical products: product id 8709, serial# (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2018, product type catheter.
If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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