Catalog Number IAP-0500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); No Consequences Or Impact To Patient (2199)
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Event Date 02/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the event occurred during use on the patient.The field service report stated that the electrocardiogram (ecg) was not communicating with the pump.The balloon had missed beats with ventricular pace and pattern trigger.The cath lab requested the pump to be checked although it was believed to be from the patient's status.There was a report of patient death.It was confirmed by the biomedical engineer that the patient was in critical condition before being put on the pump and the pump had no involvement in patient death.The field service tech checked all ecg signal and leads.Both high and low level and pacer triggers.Both operator and auto and no trigger issues.The tech ran the pump for over 2 hours and no electrocardiogram or arterial pressure (ap) trigger problem occurred, pumped on pacer triggers.The tech also performed functional checks and all passed.The pump was return to service.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "cannot detect ecg signal" cannot be confirmed.The pump was checked by the field service engineer and no problem was found with the pump.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the iabp serial/ lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The complaint will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that the event occurred during use on the patient.The field service report stated that the electrocardiogram (ecg) was not communicating with the pump.The balloon had missed beats with ventricular pace and pattern trigger.The cath lab requested the pump to be checked although it was believed to be from the patient's status.There was a report of patient death.It was confirmed by the biomedical engineer that the patient was in critical condition before being put on the pump and the pump had no involvement in patient death.The field service tech checked all ecg signal and leads.Both high and low level and pacer triggers.Both operator and auto and no trigger issues.The tech ran the pump for over 2 hours and no electrocardiogram or arterial pressure (ap) trigger problem occurred, pumped on pacer triggers.The tech also performed functional checks and all passed.The pump was return to service.
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Search Alerts/Recalls
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