MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number HL 20 |
Device Problems
Pumping Stopped (1503); Communication or Transmission Problem (2896)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/18/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2023-07-20.All the connections of the rear panel board & interconnection board were reset.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The review of the non-conformities has been performed on 2023-07-28 for the period of 2018-05-15 to 2023-07-18.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2018-05-15.A follow-up medwatch will be submitted when additional information becomes available.
|
|
Event Description
|
It was reported that during a routine check there was a ¿no comm¿ error displayed on the hl20 twin pump.No harm to any person has been reported.Complaint id: (b)(4).
|
|
Event Description
|
Complaint id: (b)(4).
|
|
Manufacturer Narrative
|
It was reported that that there was a ¿no comm¿ error 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 (b)(6) 2023.All the connections of the rear panel board & interconnection board were reset.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The reported event was assessed by the getinge life cycle engineering on (b)(6) 2023.The most probable root cause was determined as corrosion on the plug contacts, due to the age of the device and because a disconnecting and reconnecting of the cables from the sensor rack to the pump connections did solve the failure.The review of the non-conformities has been performed on (b)(6) 2023 for the period of (b)(6) 2008 to (b)(6) 2023.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on (b)(6) 2008.Based on the results the reported failure "no comm¿ error" 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.
|
|
Search Alerts/Recalls
|
|
|