Model Number MCH-1000 (M) |
Device Problems
Microbial Contamination of Device (2303); Insufficient Information (3190)
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Patient Problem
Bacterial Infection (1735)
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Event Date 02/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6) hospital submitted a user facility report (b)(4).Cardioquip followed up with (b)(6) to request the device be returned to cardioquip for investigation.(b)(6) did allow cardioquip's personnel to come onsite but personnel were not given access to the device.Additionally, at the time of this report, the device has not been returned to cardioquip for investigation and any results from testing performed on the device by (b)(6) have not been supplied to cardioquip.Cardioquip is in continuous dialogue with (b)(6) regarding their investigation and potential for the device to be returned to cardioquip at a later date.
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Event Description
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Describe the event or problem: additional details for this patient: the patient was initially cannulated for ecmo for respiratory failure related to covid infection.The patient was found to have positive sputum cultures for burkholderia.The patient was able to come off ecmo.The patient continues to be treated.The associated user facility report is mdr (b)(4).
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Manufacturer Narrative
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The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The device was found to be contaminated with the same bacteria that caused infection in the patient (burkholderia).Due to lack of access to the device, an investigation on other similar devices at the location had to be performed.The test can conclude that all of the units would be contaminated but unable to decide on whether or not the device caused the adverse event due to the limitations of the investigation performed at the facility, cardioquip is also unable to rule out the possibility of a unified source of contamination for both the heater cooler and the patient, for example, a contaminated water source.
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Event Description
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Manufacturer recieved user facility report from fda.Patient was initially cannulated for ecmo for respiratory failure.Patient was found to have positive sputum cultures for burkdoleria.
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Search Alerts/Recalls
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