Model Number 10310 |
Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is in process.A follow up report will be provided.
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Event Description
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For an mononuclear cell collection procedure, the patient's weight was inadvertently entered as 143kg.Patient's actual weight is 63kg.This was noted at approximately 112 minutes into the procedure.System calculated total blood volume (tbv): 6426ml then lowered to 3813ml at 112 minutes.Reported total amount of ac delivered: 1666ml.The customer declined to provide the patient's identifier.The patient is stable.From the patient's record: 1706ml total ac; 43 of ac in collect bag; 1666ml given to patient.Patient did develop tingling, but no other symptoms.Ca+cl 40.8meq iv, 50ml/hour given, per standing order.The disposable set is unavailable for return for evaluation.
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Event Description
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For an mononuclear cell collection procedure, the patient's weight was inadvertently entered as 143kg.Patient's actual weight is 63kg.This was noted at approximately 112 minutes into the procedure.System calculated total blood volume (tbv): 6426ml then lowered to 3813ml at 112 minutes.Reported total amount of ac delivered: 1666ml.The customer declined to provide the patient's identifier.The patient is stable.From the patient's record: 1706ml total ac; 43 of ac in collect bag; 1666ml given to patient.Patient did develop tingling, but no other symptoms.Ca+cl 40.8meq iv, 50ml/hour given, per standing order.The disposable set is unavailable for return for evaluation.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: per the customer there were mid adjustments, the patient weight was lowered down to 63kg at 112 minutes into the procedure.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: per the customer there were mid adjustments, the patient weight was lowered down to 63kg at 112 minutes into the procedure.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for this complaint.The root cause of the possible ac over infusion was determined to be due to an operator error where they entered the incorrect patient weight in the system.Correction: retraining was offered but the customer declined, confirming the issue was addressed by the customer's internal trainer.
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Event Description
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For an mononuclear cell collection procedure, the patient's weight was inadvertently entered as 143kg.Patient's actual weight is 63kg.This was noted at approximately 112 minutes into the procedure.System calculated total blood volume (tbv): 6426ml then lowered to 3813ml at 112 minutes.Reported total amount of ac delivered: 1666ml.The customer declined to provide the patient's identifier.The patient is stable and "living".From the patient's record: 1706ml total ac; 43 of ac in collect bag; 1666ml given to patient.Patient did develop tingling, but no other symptoms.Patient¿s procedure was completed successfully with no adverse effects or change in vital signs.Ca+cl 40.8meq iv, 50ml/hour given, per standing order.The disposable set is unavailable for return for evaluation.
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Search Alerts/Recalls
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