MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number ROTAFLOW

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the rotaflow "displayed no flow and only dashes were displayed".A getinge service technician was onsite to repair the affected rotaflow on (b)(6) 2021.The 701011681 rf flow measure pcba has been replaced.The device is working as intended and passed all tests.The device has been returned for clinical use.An investigation of a rotaflow system that exhibited a similar issue was performed in getinge life cycle engineering on (b)(6) 2021.The root cause is a faulty solder point between pin 4 of ic20 and the circuit board on the affected flow measure board.This resulted in a signal attenuation that jammed the generation of the ultrasonic signals.As a result the signal amplitude was only about half of the designed value and only slightly above the threshold for a reliable flow measuring.A device history review (dhr) was performed on (b)(6) 2021 and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.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

It was reported that the "liters per minute" lpm display was showing ¿---¿.The device has been exchanged with a backup device.No patient harm occurred.Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 11751248
• MDR Text Key: 248148733
• Report Number: 8010762-2021-00277
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention