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Device Problems
Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that there was low flow.They ran diagnostics and flow was 1.7lpm, inlet pressure was -7psi and the circulation pump was at 70%.They reconnected the pads one by one, and the flow range was between 1.3 lpm and 1.8 lpm.Ms&s recommended switching out the device if flow was still low and to switch out the pads.On the second device the flow was still ranging between 1.3lpm and 1.8lpm.Ms&s advised to switch out the pads.With the new set of pads on the first device, the flow was 3.2lpm.Per follow up via phone on (b)(6) 2020, the nurse stated they swapped pads.The patient was able to complete therapy with no further issues and the device was kept in service.They disposed of the first set of pads.
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Event Description
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It was reported that there was low flow.They ran diagnostics and flow was 1.7lpm, inlet pressure was -7psi and the circulation pump was at 70%.They reconnected the pads one by one, and the flow range was between 1.3 lpm and 1.8 lpm.Ms&s recommended switching out the device if flow was still low and to switch out the pads.On the second device the flow was still ranging between 1.3lpm and 1.8lpm.Ms&s advised to switch out the pads.With the new set of pads on the first device, the flow was 3.2lpm.Per follow up via phone on (b)(6) 2020, the nurse stated they swapped pads.The patient was able to complete therapy with no further issues and the device was kept in service.They disposed of the first set of pads.
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Manufacturer Narrative
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The reported event could not be confirmed.No sample was returned for evaluation and the lot number is unknown.It is therefore unknown if the device failed to meet specification.The device was being used for treatment at the time of the reported event.A potential failure mode could be ¿incorrect water flow¿.A potential root cause for this failure could be " inadequate channel design".The lot number is unknown therefore the device history record could not be reviewed.A labeling review is not required.The product code for this z300-unknown articgels pads product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the z300-unknown articgels pads product labeling is found to be adequate based on past reviews.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Search Alerts/Recalls
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