MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number HL 20

Device Problem Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when new information becomes available.

Event Description

It was reported that the hl20 heart lung machine stopped.Further information is pending.Reference number: 393311.

Manufacturer Narrative

Device was manufactured in 2010-08-19.The review of the non-conformities during the period of 2010-08-19 to 2020-11-17 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 can be excluded.According to the field service technician (fst) the investigation was performed as follows: the pump made a strange noise when it was running and sometimes showed error message: "error head".The tachometer was replaced which solved the head error.The noise of the pump still remained.According to the fst the pump motor will be replaced.The getinge technical service suggested to replaced the whole motor because it is assumed that a defective bearing is the root cause of the noise.The reported failure was "error message: error head / noise when pump is running".A similar complaint ((b)(4)) with the reported failure was already investigated.According to the life cycle engineering report# (b)(4) dated on 2019-08-26 the most probable root cause is a broken wiring of the tachoboard.The most probable root cause of the pump noise could be determined as a defective bearing.The reported failure "error head and strange noise of the pump" could be confirmed.The reported failure "error head and strange noise of the pump" did not happen during patient treatment.The hl20 in question was responsible for this complaint/event.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.

Event Description

Reference number: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10913795
• MDR Text Key: 218525623
• Report Number: 8010762-2020-00409
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HL 20
• Device Catalogue Number: 70102.8581
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1