Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2022 |
Event Type
malfunction
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Event Description
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The event occurred in germany.It was reported that the affected hls set has a packaging issues as known from fsca-656504.The set was checked by the customer in regards to the fsca.The failure was noticed before use and no patient was involved.No harm to any person has been reported.Complaint id: (b)(4).
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Manufacturer Narrative
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The investigation is ongoing.A follow-up emdr will be submitted when additional information becomes available.A field safety corrective action (fsca#656504) has been implemented on july 2022.The hls set advanced is intended for use in an extracorporeal circulation for cardiac support and/ or pulmonary support.Maquet cardiopulmonary gmbh (mcp) has received customer complaints of damage to the primary packaging of the hls set advanced.In all customer complaints it was reported that the tyvek cover was damaged.The appearance of the packaging failure can be hole(s) in the tyvek.The damages are caused by the tabs of the venous probe holder within the packaging.To improve the detectability of the damage actions have been implemented which includes the return of the products and a customer on-site device inspection.
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Manufacturer Narrative
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It was reported that the affected hls set has a packaging issue as known from fsca-656504.The set was checked by the customer in regards to the fsca.A hole in the tyvekcover could be detected.The affected hls sets was sent to the customer before the fsca was initiated.The failure was noticed before use and no patient was involved.No harm to any person has been reported.The product is not available, as it was scrapped.Therefore a technical investigation could not be performed at the getinge laboratory.The picture provided by the customer shows the hole in the tyvekcover.A review of the complaint data for similar complaints was performed and the reported failure was already investigated in a similar complaint.The most probable root cause could be determined that the straps moved upwards leading to a loose position.This lead to an unsecured hls module which perforated the tyvekcover with the venous measuring cell, e.G.During transport or due to impacts from outside.The affected be-hls 7050 #shls set advanced 7.0 with lot#3000218625 has been reviewed for the reported failure on 2022-10-18.According to the final test results, the hls set with the lot# 3000218625 passed the tests as per specifications.Based on the investigation results and the provided picture the reported failure "hole in tyvekcover" could be confirmed.Maquet cardiopulmonary initiated a capa process in order to take further actions.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : 4115.
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Event Description
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Complaint id: (b)(4).
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Search Alerts/Recalls
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