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

Model Number ROTAFLOW ENGLISH/US US-PLUG ICU

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

The event occurred in the usa during pre-use setup of the rotaflow.It was reported that the error message ¿b temp¿ was displayed on the rotaflow console, and that the rotaflow emergency-drive handle was damaged.No harm to any person has been reported.Complaint id (b)(4).

Manufacturer Narrative

The event occurred in the usa during pre-use setup of the rotaflow (rf).It was reported that the error message ¿b temp" error was displayed on the rotaflow console, and that the rotaflow emergency-drive (rfe) handle was damaged.No harm to any person has been reported.A getinge service technician investigated the rotaflow console (rfc) with serial number (sn) (b)(6).The technician confirmed the reported failure and replaced the "battery pack with fuse" (material# 70101.7188).The technician also investigated the rfe with sn (b)(6) and replaced the "rfe hand crank assy" (material# 70103.7579).After the replacements the rotaflow is working as intended.An investigation of a rotaflow system that exhibited a similar issue "b temp error" has been performed by getinge life cycle engineering: the most probable root cause could be determined as a displaced contact due to incorrect assembly of the connector on the battery pack, which led to the reported "b temp" error.The most probable root cause for the damaged emergency drive handle could be identified as normal wear and tear of the device (produced in 2015).Based on these investigation results the reported failures "b temp error" and "rotaflow emergency-drive damaged" could be confirmed.A review of non-conformities was performed on 2023-12-07, and during the time from 2015-09-15 to 2023-12-07 there are no non-conformities 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 in question was produced on 2015-09-15.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 18291692
• MDR Text Key: 330133369
• Report Number: 8010762-2023-00612
• 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: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH/US US-PLUG ICU
• Device Catalogue Number: 701051712
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1