Catalog Number 0998-00-3023-XX |
Device Problems
Loss of Power (1475); Pumping Stopped (1503); Device Displays Incorrect Message (2591)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Event Description
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On (b)(6)2017, it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification).
Further, it was reported the iabp had shutdown/pump stopped.
On (b)(6)2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.
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Manufacturer Narrative
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On (b)(6) 2017 06:37 pm (gmt-5:00) added by (b)(6) (b)(4): the production device history record (dhr) for the iabp involved in the event was reviewed.
There were no non conformances noted in the dhr related to the reported event.
The company field service engineer (fse) evaluated the unit and reviewed the fault logs.
The following was reported: the fse was able to confirm the event based on the review of the logs.
Further, the pump assembly (part number (b)(4) was replaced and sent to the manufacturer for further evaluation.
The pump assembly is still under investigation and the investigation results are pending.
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Event Description
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On (b)(6) 2017, it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification).
Further, it was reported the iabp had shutdown/pump stopped.
On (b)(6) 2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.
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Manufacturer Narrative
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The replaced part/component, pump assembly (part number 0102-00-0001) was returned to the manufacturing facility for further evaluation.
The pump failed testing, the reported failure of "electrical test fails code #50" was verified, and pump does not power up.
The company representative disassembled the pump assembly and removed the vacuum and pump heads.
The vacuum head internal parts were intact.
The internal pressure head parts showed physical damage inside.
The retaining screw holding the clamping disc was warped and the clamping disc wore through the head of the retaining screw.
Metal filings inside the pump were also observed.
The company representative replaced the retaining screw and the clamping disc of the pressure head, reassembled the pump assembly, and tested the pump to factory specifications.
Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.
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Event Description
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On (b)(6), it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification).
Further, it was reported the iabp had shutdown/pump stopped.
On (b)(6) 2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.
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Search Alerts/Recalls
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