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

Model Number MCP00706291#ROTAFLOW PUMP MODULE

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2021

Event Type  Death  

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 (b)(6).It was reported that the rotaflow console reported an ¿txrx error¿.Initial it was reported that the affected console is still used on patient.Later, new information received that the patient has died.The patient died in the early morning of (b)(6) 2021.Technician got this final information after getting in touch with the head nurse of the hospital on (b)(6) 2021.It was confirmed by the customer that they did not use this rotaflow for the procedure due to equipment failure.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in china.It was reported that the rotaflow console reported an ¿txrx error¿.Initially it was reported that the affected console is still used on patient.Later, new information was received that the patient has died.The patient died in the early morning of (b)(6) 2021.Technician got this final information after getting in touch with the head nurse of the hospital on (b)(6) 2021.It was confirmed by the customer that they did not use this rotaflow for the procedure due to equipment failure.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician on (b)(6) 2021 and was able to reproduce the reported failure.The (b)(6)#flow measure board for rfc (rotaflow console) (article number (b)(6)) has been replaced.After the replacement the device is working as intended.The affected part (b)(6)#flow measure board for rfc (rotaflow console) (article number (b)(6)) was send back to the manufacturer for investigation.The part was investigated by the getinge life-cycle-engineering (lce) and the reported failure "txrx error" could be confirmed.The probable cause was determined as defect of the signal amplifier ic26 on the flow measure board which led to the reported failure.The probable cause for the defect is statistical component failure.The reported failure and the application method described by the customer was evaluated by getinge medical affairs department on (b)(6) 2021 following outcome: the limited correspondence from the clinic indicates that treatment was not initiated because of the reported failure mode.The clinic reported all available rotaflow systems were in use.The contingency plan reported by the clinic when an additional system is required emergently requires borrowing a system from another clinic.The device was not functioning correctly as described in the complaint.The reviewer cannot conclude the patient outcome was solely or partially related to the reported rotaflow failure mode.A delay in treatment may be associated with morbidity and mortality in acutely ill patients requiring extracorporeal support; however, the correspondence from the clinic lacks the detail to come to a definitive conclusion.Based on the investigation results the reported failure "txrx error" could be confirmed.A device history record (dhr) review was performed on (b)(6) 2021.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.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: 12466565
• MDR Text Key: 271227640
• Report Number: 8010762-2021-00497
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706291#ROTAFLOW PUMP MODULE
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death