Model Number 0684-00-0469-01 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter occupation: bsn, rn, director of cardiovascular services/administrator/supervisor.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Event Description
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It was reported that the customer noticed a liquid-type condensation on their intra-aortic balloon.Upon inspection, it was reported that seven other iabs were affected with the same issue.There was no patient involvement and no adverse event was reported.This report is for the second of eight iabs.Separate reports will be submitted for the other seven iabs.
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Event Description
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It was reported that the customer noticed a liquid-type condensation on their intra-aortic balloon.Upon inspection, it was reported that seven other iabs were affected with the same issue.There was no patient involvement and no adverse event was reported.This report is for the second of eight iabs.Separate reports will be submitted for the other seven iabs.
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Manufacturer Narrative
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The product has been returned to the manufacturer but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Reference complaint # (b)(4).
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Manufacturer Narrative
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An evaluation was performed of the returned product.It has not been exposed to any clinical or known biohazardous conditions.The catheter kit and insertion kit were returned intact and sealed.The evaluation consisted of a visual inspection confirming the presence of a clear fluid inside the kits.An iab remove from retainers test was performed on the device and recorded the peak force that was required to remove the iab from the retainer, as indicated on the gage.The device was reported to contain a liquid type condensation inside the packaging.Infra-red spectrophotometer results confirmed that the substance was silicone which had migrated from inside of the packaging during shipping/storage.Silicone is used as a lubricant during the manufacturing process and has been determined to be biocompatible.Devices with silicone found in the packaging can continue to be used and pose no risk to the patient per iab product specification.This silicone is not foreign matter and is not a nonconformity of the device.The reported event for silicone migration is confirmed.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period (b)(6) through (b)(6) was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4)>.
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Event Description
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N/a.
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Search Alerts/Recalls
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