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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 18087181, medical device expiration date: 08/29/2021, device manufacture date: 08/29/2018; medical device lot #: 18096594, medical device expiration date: 09/21/2021, device manufacture date: 09/21/2018; medical device lot #: 18087069, medical device expiration date: 08/28/2021, device manufacture date: 08/28/2018; medical device lot #: 18096593, medical device expiration date: 09/20/2021, device manufacture date: 09/20/2018; medical device lot #: 18075969, medical device expiration date: 07/27/2021, device manufacture date: 07/27/2018; medical device lot #: 18075970, medical device expiration date: 07/27/2021, device manufacture date: 07/27/2018.Investigation summary: a mz5303 sample was not available for investigation of this feedback; however the customer indicates that the clamp component did not occlude the flow whilst in the closed position which resulted in drug overinfusion.Investigation conclusion: the details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lots 18087181, 18096594, 18087069, 18096593, 18075969 and 18075970 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.Please note that previous investigations into similar reports of this nature have identified that uncontrolled flow can occur if the tubing is not positioned centrally inside the pinch clamp when in the occluded position.The tube must be positioned centrally when using a pinch clamp, ensuring that no part of the tubing is visible either side of the clamp.A review of the customer feedback database indicates that this is an isolated occurrence with no other similar report against the mz5303 set in the past 12 months.Root cause analysis: dhr for the affected lot numbers: pr: (b)(6), lot: 18087181, model: mz5303, qty: (b)(4), qn/deviation: none, mfg date: 29-aug-18; 18096594, mz5303, (b)(4), none, 21-sep-18; 18087069, mz5303, (b)(4), none, 28-aug-18; 18096593, mz5303, (b)(4), none, 20-sep-18; 18075969, mz5303, (b)(4), none, 27-jul-18; 18075970, mz5303, (b)(4), none, 27-jul-18.
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It was reported that the pressure rated ext set, iv connector experienced flow issues, overinfusion, and a defective/damaged tubing clamp.The following information was provided by the initial reporter: 30cc of medication was infused with using mz5303 by syringe pump.When the customer saw the remaining volume of the medication, actual infused medication was 35cc.The customer performed the investigation then it was found that even if clamp was closed, when mz5303 was pressurized with using syringe pump, the clamp cant stop the flow.No health hazard to patient was reported.
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The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: 07/27/2020.Investigation conclusion.Fifty mz5303 samples from lot 18096595 were received for investigation in sealed packaging.A visual inspection did not identify signs of damage or manufacturing defects which could have contributed to the customer's experience.The samples were subjected to clamp occlusion testing; no fluid movement was observed beyond the clamp throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lots 18087181, 18096594, 18087069, 18096593, 18075969 and 18075970 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined in this instance.Testing of the returned samples did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.Please note that previous investigations into similar reports of this nature have identified that uncontrolled flow can occur if the tubing is not positioned centrally inside the pinch clamp when in the occluded position.The tube must be positioned centrally when using a pinch clamp, ensuring that no part of the tubing is visible either side of the clamp.A review of the customer feedback database indicates that this is an isolated occurrence with no other similar report against the mz5303 set in the past 12 months.
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It was reported that the pressure rated ext set, iv connector experienced flow issues, overinfusion, and a defective/damaged tubing clamp.The following information was provided by the initial reporter: 30cc of medication was infused with using mz5303 by syringe pump.When the customer saw the remaining volume of the medication, actual infused medication was 35cc.The customer performed the investigation then it was found that even if clamp was closed, when mz5303 was pressurized with using syringe pump, the clamp cant stop the flow.No health hazard to patient was reported.
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