Model Number 2110 |
Device Problems
Volume Accuracy Problem (1675); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the reason for the return of the device was due to failed preventive maintenance for volume amounts and power issues.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Other, other text: b5: describe event or problem: updated with additional information received.H6: event problem and evaluation codes: updates are not required.H10: no sample has been received by manufacturing.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available., corrected data: h3: correction: device evaluated by manufacturer: should have stated device not returned to manufacturer.
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Event Description
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Additional information was received by the manufacturer on (b)(6)2022 via email and attached in the complaint object: this is during preventative maintenance, no patient interaction.
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Manufacturer Narrative
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H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.The device was received in used condition.No tamper seal was on the device.No evidence of the issue was found in the event history log.The reported complaint was not verified.The investigation was unable to duplicate the customer problem, three separate delivery accuracy tests were performed.The pump was slightly over delivering but within the published specification.The power issue was not duplicated.The reported problem was caused by the expulsor; however, no problem was found for the power issue.The root cause was traced to issues from previous repairs.For corrective action it was recommend that the pumps expulsor be trimmed in order to bring the delivery into more nominal of a range.The root cause was unknown.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record review was not performed.Service history review identified this device has not been in for service previously.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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