Model Number 8120 |
Device Problems
Contamination (1120); Crack (1135); Failure to Align (2522); Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.
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Event Description
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It was reported by the customer that the device fails barrel clamp open test.There was no additional information provided and no patient involvement.
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Event Description
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It was reported by the customer that the device fails barrel clamp open test.There was no additional information provided and no patient involvement.
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Manufacturer Narrative
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This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that pca sizer misalign recall completed.Replaced sizer sensor, front cover, rear case, left/right handle, module key lock label, and left/right iui.The failure code othe was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.A review of the device history record showed the device had a manufacture date of 17feb2016.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Based on the findings, service determined that the probable root cause of the reported issue was due to mechanical failure of the assembly bkt clp sizer sensor a review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
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Manufacturer Narrative
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Additional information added to: e2, g2 for biomed as health professional.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that pca sizer misalign recall completed.Replaced sizer sensor, front cover, rear case, left/right handle, module key lock label, and left/right iui.The failure code othe was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.Based on the findings, service determined that the probable root cause of the reported issue was due to mechanical failure of the assembly bkt clp sizer sensor.A review of the device history record showed the device had a manufacture date of 17feb2016.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the sn (b)(6) did not confirm similar complaints with the same or related failure mode for this customer.
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Event Description
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It was reported by the customer that the device fails barrel clamp open test.There was no additional information provided and no patient involvement.
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Search Alerts/Recalls
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