MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number ROTAFLOW DRIVE UNIT, BLUE

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

The following information was received: "it was reported that end user reported to the biomed (authorized person in the hospital for technical issue on the devices) that the rotaflow drive does not have any flow.No patient was injured or harmed." complaint id: (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

A getinge field service technician was on site to investigate the device in question on 2019-12-13.According to the service order 43199729 the unit was tested.Problem was not repeatable.Ran the rfd for over a week.All tests passed.Additionally the one year service was performed, pm, calibration check, full functional test as per the service manual.Rfd passed all tests.As no failure was detected no probable root cause could be determine.It is unknown when the reported failure "no flow" occurred and the failure could not be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9449167
• MDR Text Key: 199894509
• Report Number: 8010762-2019-00389
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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 DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 12/17/2019
• Patient Sequence Number: 1