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

Model Number ROTAFLOW JAPANESE US-PLUG ICU

Device Problem Pumping Stopped (1503)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event occurred in japan.It was reported that during clinical use of the rotaflow console and drive an error suddenly occurred and the rotation stopped.The hospital staff was too busy treating patients to remember what error message was displayed exactly.The rotaflow console and drive were replaced with no consequences for the patient.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in japan.It was reported that during clinical use of the rotaflow console and drive the error message "head error" occurred and the pump stopped.The rotaflow console and drive has been replaced with no consequences for the patient.No harm to any person has been reported.A getinge service technician was on site to investigate the affected rotaflow console with s/n (b)(6) and the rotaflow drive with s/n (b)(6).The technician was able to confirm the reported "head error".During the investigation by the technician a worn out lemo master connector was detected which lead to a interrupted communication between the rotaflow console and drive.The connection cable rf drive socket (article number 701034666) has been replaced.After the replacement the device is working as intended.The following most possible root cause for the reported "head error" could be determined as a worn out lemo master connector which lead to an interrupted communication between the rotaflow console and drive which caused the "head error".Based on these investigation results the reported "head error" could be confirmed.Rotaflow console s/n (b)(6) the review of the non-conformities was performed on (b)(6) 2022 and during the period from (b)(6) 2012 to (b)(6) 2022 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow console was produced (b)(6) 2012.Rotaflow drive s/n 91063913 the review of the non-conformities was performed on (b)(6) 2022 and during the period from (b)(6) 2012 to (b)(6) 2022 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow drive was produced 2012-10-01.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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

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: 15822088
• MDR Text Key: 303913215
• Report Number: 8010762-2022-00454
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW JAPANESE US-PLUG ICU
• Device Catalogue Number: 701051711
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose