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 Problem Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

This is the initial importer report- (b)(4) to complaint (b)(4) that was initially reported under mfr.Report# 8010762-2022-00153 on (b)(6) 2022 as a malfunction (now being reported as a death) which is a duplicate entry to complaint (b)(4), reported under mfr.Report# 8010762-2022-00150 on (b)(6) 2022 and (b)(4).

Event Description

It was reported that the displayed flow of the rotaflow is under delivering setting where at 5 lpm.The failure occurred during patient treatment.Ref (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: 14373295
• MDR Text Key: 293334892
• Report Number: 3008355164-2022-00013
• 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: Distributor
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2022
• Distributor Facility Aware Date: 05/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2022
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death