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 08/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Further investigation is ongoing.A follow up medwatch will be submitted when additional information becomes available.A field safety corrective action (fsca#(b)(4)) has been implemented on (b)(6) 2022.The hls set advanced is intended for use in an extracorporeal circulation for cardiac support and/ or pulmonary support.Maquet cardiopulmonary (b)(4) (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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Event Description
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It was reported that the affected hls set has packaging issues as known from fsca-(b)(4).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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It was reported that the affected hls set has 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.The affected product was not available for further investigation.Therefore a technical investigation could not be performed at the getinge laboratory.However according to the ssu the damage on the tyvek cover could be confirmed.The affected product: 701069073 be-hls 7050 #shls set advanced 7.0 with lot#3000217597 has been reviewed for the reported failure on 2022-10-26.Following tests are performed according to the bop 145 as a 100 % inspection: welding of inlay, control of packaging, final tests, according to the final test results, the hls set with the lot# 3000217597 passed the tests as per specifications.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.
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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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