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Model Number 21-3369-24 |
Device Problems
Loose or Intermittent Connection (1371); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that the microclave unscrewed from the gripper throughout the treatment with an infusor.It occurred with 4 patients and at the end of the treatment there was a lot of bleedback obstructing the line.There was spillage of drug and blood through the connection of the microclave and gripper.There was blood loss, bleedback, chemo, and biohazard.The device was not reprocessed or re-sterilized.There is a used contaminated sample and sister samples available for evaluation.Five pictures of the product issue were provided.The event occurred during patient use; however, there was no need for medical intervention, no delay in therapy, no adverse event and no one was harmed as a result of this event.No patient injury was reported.Additional information received on 20-dec-2022: received an email from the sales representative on 20-dec-2022, stating that the microclave was unscrewing from the luer of the gripper while the infuser treatment was passing.When the microclave was loosened from the gripper connection, blood flew back as the gripper was opened.The blood refluxed from the port-a-cath into the elastomer when the drug finished passing.The gripper was placed for treatment through pump during the day in the hospital and then the infuser was placed, which was taken home by the patient for 48 hours.The four incidents occurred with different nurses.
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Manufacturer Narrative
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Device evaluation, 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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Manufacturer Narrative
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Customer reported 5 units and 5 complaints were made.Only 3 samples were received: two gripper devices were returned without its original packaging.An additional microclave component was provided with the samples.This component was determined to not be part of the original gripper kit, or manufactured by icu.One photo was also attached to the complaint, demonstrating a disconnection between two components, however the pictured components were identified as not part of the gripper sets.The complaint returned units were visually inspected.No damage or other defects were detected in the first sample.Dry liquid remains were observed in the second sample, which the investigation noted may block the fluid path of sample two.Sample one was connected to a syringe to inject the water pass through the whole product and no leaks or occlusions were detected.Sample two was not tested due to the contamination observed in the fluid path, which was identified as potentially being blood contamination.Both samples were connected to the microclave returned by the customer, to test connection problems in the connection area, and both samples were connected without problem.A review of manufacturing device history reccords for the reported lot number found no discrepancies or anomalies that could result in the reported issue.Based on the available information, the investigation was unable to re-produce or confirm the reported issue, and no root cause could be established.No actions have been taken at this time.
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Search Alerts/Recalls
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