DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-55 |
Device Problems
Moisture Damage (1405); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device, a getinge therapy development manager (tdm) was dispatched to evaluate this unit.On (b)(6) 2021 tdm successfully carried out water condensation removal procedure on cardiosave.The pump ran for 2 hours without any problems or condensation formation.The iabp unit was then released to be used by senior physicians on a patient.Customer was advised to get in touch with tdm immediately if water becomes visible again in the helium tube.On (b)(6) 2021 tdm responded to service call that condensation had formed again in the helium tube of the cardiosave.The machine was taken out of service and replaced with a cs300.It was advised that getinge field service engineer (fse) will come out to replace cardiosave's crm unit.A separate mdr will be reported for the second condensation event reported.On (b)(6) 2021 the cardiosave was evaluated by fse, who replaced pneumatic module assembly (0997-00-1178) along with nafion hoses.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon receipt of additional information or completion of our investigation.
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Event Description
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It was reported that during use the cardiosave intra-aortic balloon pump (iabp) had relatively strong water condensation in the helium tube.The iabp runs together with a va-ecls system.The ambient conditions were normal, the patient had no fever.Since a "gas loss in the iab system alarm" occurred in the course of the therapy, the users replaced the system with a cs300 iabp.The device was delivered to the customer as a used device on september 13th, 2021.Patient therapy was not delayed.Therapy is still ongoing, iabp ran together with ecls system.There was no harm or injury to the patient and no adverse event was reported.Patient height (b)(6).
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Manufacturer Narrative
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Updated fields: b4, g4, g7, g8, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: g1 (contact person ¿ mfg site).
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Event Description
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N/a.
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Search Alerts/Recalls
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