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

Model Number ROTAFLOW

Device Problems No Display/Image (1183); Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the flow gradually decreased until the error message "---" was displayed.

Event Description

Complaint id:(b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflows displays "no flow displayed only ---".The failure occurred during patient treatment.According to the communication grid dated on 2021-01-11 a getinge service technician was onsite to test the affected rotaflow and could confirm the reported failure.It was found that the 70101.1681 rfc (rotaflow console) flow measure board needs to be replaced.A similar failure was already investigated in complaint (b)(4) by the life-cycle-engineering (lce) in the report lce04459 with the following most probable root cause: 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.The device was manufactured on 2020-02-06.The device history record (dhr) of the rotaflow console (material: 70104.6405, serial: (b)(6)) for which a customer complaint was received, was reviewed on 2020-11-09.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Based on these investigation results the reported failure could be confirmed.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: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10792325
• MDR Text Key: 214785270
• Report Number: 8010762-2020-00376
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• 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: 70104.6405
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention