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Model Number N/A |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identifier: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
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Event Description
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The user facility reported that the tr band device was placed in lab.The patient was moved across the hall to recovery when the band was discovered to be deflated.A new band was placed, and the patient was monitored during recovery.There was no hematoma or additional complications noted.The patient was in good condition.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One large tr band assembly was returned to terumo medical corporation for product evaluation.The returned components were subjected to visual inspection and no anomalies were noted.The return device was inflated with 15 ml of air and submerged in water.Air bubbles were noted at the communication port between the large and small balloons.The communication port was visually inspected, and it was noted that the communication port was partially ripped apart.The complaint can be confirmed for airflow issues.It is likely that the balloons were attempted to be separated prior to inflating which could have caused the rip in the communication port therefore resulting in the air leakage.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).
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Search Alerts/Recalls
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