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

Model Number MCP00706041#ROTAFLOW ENGLISH/UK UK-PLUG

Device Problem Increased Pump Speed (1501)

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

Event Date 06/15/2022

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 india.It was reported that the error message ¿run away error¿ occurred on the rotaflow console before use and no patient was involved.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in india.It was reported that the error message ¿run away error¿ occurred on the rotaflow console before use and no patient was involved.No harm to any person has been reported.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the technician was able to reproduce the reported failure "run away error".The rf (rotaflow) control board pcba (printed circuit board assembly) kit (article number (b)(4)) and the rf flow measure pcba (article number (b)(4)) has been replaced.After the replacement the device is working as intended.The affected control and flow measurement board were requested for further investigation but both boards are not available for investigation.Based on the investigation results the reported failure "run away error" could be confirmed.The failure mode "run away error" can be linked to the following most possible root causes according to the rotaflow risk management file.Defective motor control electronics, pump stop intervention after technical error (e.G.Pump runaway, error head), software error, wrong intervention limits.The review of the non-conformities was performed on (b)(3) 2022 and during the period of (b)(3) 2019 to (b)(3) 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 in question was produced in (b)(3) 2019.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: 14753233
• MDR Text Key: 301915743
• Report Number: 8010762-2022-00233
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706041#ROTAFLOW ENGLISH/UK UK-PLUG
• Device Catalogue Number: 701043291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose