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

Model Number 701028581 - HL 20

Device Problem Pumping Stopped (1503)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

According to the support case#(b)(4) and the service protocol (order no#(b)(4)) date on (b)(6) 2019 the technician performed as follows: the technician tested the pump in each of the modes and it works correctly.No safety or function defects detected.Verified the bubble sensor and detected a damaged cable (fracture near the head of the cable) which caused the problem.The customer will buy a new sensor and the machine is out of clinical use until they get the new one.Thus the reported failure could be confirmed.A similar case (sap#(b)(4)) was already investigated by the supplier em-tec.According to the e-mail received from the supplier the most probable root cause for the broken cable is too high mechanical stress (cable was bend too often), which finally led to a fracture of the cable.Since this is a user error, no remedial action is required.The occurrence rate of this error is below the acceptable rate.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Customer reported that the heart lung machine hl20 pump stopped during a case because of a defective bubble sensor cable.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
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 9249393
• MDR Text Key: 200659575
• Report Number: 8010762-2019-00341
• 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
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701028581 - HL 20
• Device Catalogue Number: 70102.8581
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1