MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 HLS SET ADVANCED 7.0; TUBING, PUMP, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number BEQ-HLS 7050 |
Device Problem
Defective Component (2292)
|
Patient Problem
Death (1802)
|
Event Date 12/15/2018 |
Event Type
Death
|
Manufacturer Narrative
|
(b)(4).Lab investigation at the factory: a beq-015703112#hls module advanced adult was delivered as a complaint sample.An optical examination and a tightness test according to lv 201 (blood side) were carried out.The results of the tests were documented in writing and pictures and filed in the complaints folder.The optical examination of the oxygenator did not reveal any detectable defects.While cleaning and flushing the gas side, a clot was flushed out at the gas outlet.In the subsequent leak test according to lv 201, a leak was found on the pressure sensor located on the blood inlet channel.The adhesive connection between the pressure sensor and blood inlet channel is not ok.In order to perform another leak test to check the tightness from the gas to the blood side of the oxygenator, the leaky adhesive connection from the pressure sensor to the blood inlet channel had to be sealed.After the sealing of this leaky spot a leak test according to lv 201 was carried out again and a leakage from the blood side to the gas side was detected.The mfr report # for this event is 8010762-2019-00006.
|
|
Event Description
|
According to the customer: customer put a patient on cardiohelp on (b)(6) 2018, and noted blood from the exhaust port on the oxygenator.The oxygenator failed at hour 24.Patient co2 remained normal-co2 on oxygenator in the 90s venous and arterial.Circuit was changed out and patient only off pump for 4 minutes.They also had impella running at 2l.Patient became non responsive at midnight on (b)(6) 2018.(b)(4).On march 5, 2019: the factory was informed that after requesting the outcome of the patient, the complaint initiator forwarded information that the patient expired.This information was sent to the ssu on march 13, 2019 which necessitated the filing of a importer e-mdr- this report.The mfg report # for this event is # 8010762-2019-00006.
|
|
Search Alerts/Recalls
|
|
|