MAUDE Adverse Event Report: JULIA KAPFENBERGER 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 Type  malfunction  

Manufacturer Narrative

Customer reported that error message "head error" appeared on the roller pump module of the hl 20 machine during checking.No harm to any person was reported.A getinge field service technician (fst) was onsite and investigated the unit in question.The hl 20 machine was checked and it was found that the optical tacho board is defective and needs to be replaced.Thus the reported failure could be confirmed.The reported failure "head error" has been investigated in a previous complaint on (b)(6) 2019.The most probable root cause could be determined as a broken wiring of the optical tachoboard.The device in question was manufactured on 2013-05-16.The review of the non-conformities during the period of 2013-05-16 to 2022-07-28 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.

Event Description

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

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15127703
• MDR Text Key: 304358377
• Report Number: 8010762-2022-00290
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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: 701043262
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose