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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

Customer reported that error message "head error" appeared on the twin roller pump module of the hl 20 machine during set up.No harm to any person was reported.Complaint id #(b)(4).

Manufacturer Narrative

Customer reported that error message "head error" appeared on the twin roller pump module of the hl 20 machine during set up.No harm to any person was reported.A getinge field service technician (fst) was onsite and investigated the unit in question.The fst found that the belt kit was defective and needs to be replaced.It was also confirmed that the belts were due for replacement (replacement of belts in a service intervall of 12 months according to the hl 20 service manual).Thus the reported failure could be confirmed but no product related malfunction.The reported failure "head error" was investigated in a previous complaint on 2020-05-28.The following causes can be considered as the cause of the defective belts: belt profile error causing them to not run properly in the rpm pulleys.Different height of the two pulleys.Belt pulley profile error.Faulty belt tension.In order to avoid the reported failure the getinge sales and service will be informed to follow the instructions below in the hl 20 service manual referring to the hl 20 service manual in chapter replacement of belts on rpm (roller pump module) the following is stated: replace belts which are found twisted, have wear, cracking, or service life over 12 months.The product in question was produced in 2014-09-26 the review of the non-conformities during the period of 2014-09-26 to 2022-05-16 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 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.

• 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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 14425796
• MDR Text Key: 293692334
• Report Number: 8010762-2022-00171
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: HL 20
• Device Catalogue Number: 701028580
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose