MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Model Number HL 20 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that the pump stopped and could not be restarted.The failure occurred during a routine check.No harm to any person has been reported.Complaint id: (b)(4).
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Manufacturer Narrative
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The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-31.The motor control board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The device was manufactured on 2021-12-21.The device history record (dhr) of the hl20 was reviewed on 2023-09-12.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.A follow-up medwatch will be submitted when additional information becomes available.
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Manufacturer Narrative
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It was reported that the pump stopped and could not be restarted.The failure occurred during a routine check.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2023 (b)(6).The motor control board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The defect motor control board was investigated by the getinge life cycle engineering on 2024 (b)(6).Two fuses f1 (+5v) and f2 (+12v) were identified as defective.The most probable root cause was determined as originating outside of motor control board, because after replacement of those fuses the board is functioning again according to specifications.Based on the results the reported failure "pump stopped and could not be restarted" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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Event Description
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Complaint id: (b)(4).
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