Model Number BEQ-HLS 7050 USA#HL |
Device Problems
Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/23/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.(b)(4).
|
|
Event Description
|
It was reported that blood drip from vent port of the hls module detected during <2 hours after initiating support.No leak noted during priming.Gas transfer not affected during pt support.Increasing rate of blood drip.Concern for clotting vent port.Circuit changed out.No harm to the patient was reported.(b)(4).
|
|
Manufacturer Narrative
|
(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).The product was requested for return to the manufacturer for laboratory investigation.Sample was investigated in the laboratory on 2018-06-11: an hls module advanced 7.0 has been returned.The sample was contaminated.Sample cleaned with sodium hypochlorite.The visual inspection detected a damaged luer lock on the blood outlet side.It is not necessary to test the sample for leaks since the damage to the luer lock is visible.No abnormalities were noted on the screw cap.No further damage or other abnormalities were found.Conclusion: a leak can be confirmed.The visual inspection was a damaged luer lock of the blood outlet side.To test the pattern for tightness is not necessary since the damage on the luer lock is too big.On the screw cap were no abnormalities detected.No further damage or other abnormalities were found.Thus the failure could be confirmed.The most probable cause could be determined as excessive or inadequate external physical force that was exerted on the product after the release.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
|
|
Event Description
|
(b)(4).
|
|
Search Alerts/Recalls
|