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

Model Number ROTAFLOW

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Further information has been requested but has not yet been received.

Event Description

It was reported that the rotaflow drive holder will not stay in place.The reported failure occurred during patient treatment.The holder has been fixated with tape.No patient harm occurred.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow drive (rfd) "holder cannot be tightened".The failure occurred during patient treatment.The rotaflow drive holder has been fixated with tape to finish the treatment.No patient harm occurred.A third party engineer was on site to repair the affected rotaflow (serial#(b)(6)).The technician added hydraulic oil to the rfd holder (material#70103.4026).After the oil was added the device is working as intended and determined the most probable root cause as a screw that has not been tightened enough.Based on these investigation results the reported failure could be confirmed.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 could have led to the customer complaint.In order to avoid reoccurrence of the reported failure, the user will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.2 | en | v13.Chapter 4.1.3: make sure that the screws are firmly tightened and that the rotaflow drive is securely fixed in place.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

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: 12873351
• MDR Text Key: 281266571
• Report Number: 8010762-2021-00626
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991864
• 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,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• 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: 701046405
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention