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

Model Number ROTAFLOW GERMAN EU-PLUG ICU

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

It was reported that the locking flap for pump segment (closing assy) is broken.The failure occurred during patient treatment.The device has not been exchanged during treatment.The customer used a band to fixate the broken part.No harm has been reported.Complaint id: (b)(4).

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.

Manufacturer Narrative

It was reported that the locking flap for pump segment (closing assy) is broken.The failure occurred during patient treatment.The device has not been exchanged during treatment.The technician of the hospital used tape to fixate the closing assy to the rotaflow.No harm to any person occurred.A getinge service technician was on site on 2022-04-26 to check the affected rotaflow drive (rfd) (serial#(b)(6)).The technician confirmed the reported failure and gave the rfd closing assy (material#701011680) to the technician of the hospital, since the device has still been in use on the patient.The technician from the hospital will replace the rfd closing assy (material#701011680).An investigation of a rotaflow system that exhibited a similar issue "closing assy broken" was performed in getinge life cycle engineering on 2016-11-02.Most probable root causes could be determined: - too excessive force; - weakening due to manufacturing errors (air inclusions).The product in question was produced in 2020-07-01.The device history record (dhr) of the rotaflow (material:701022161 , serial: (b)(6), elo#:1072939) for which a customer complaint was received, was reviewed on 2022-04-22.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.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.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.

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: 14278069
• MDR Text Key: 291307522
• Report Number: 8010762-2022-00144
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW GERMAN EU-PLUG ICU
• Device Catalogue Number: 701022161
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention