MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number ROTAFLOW CONSOLE

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The device was investigated by a maquet service technician: the control pcba kit(rfc) was exchanged.The device was checked and was checked safe to operate.The defective control board will be investigated for further actions at (b)(4).

Event Description

(b)(4).Before use/procedure a head error was shown on the display.

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer: maquet medical systems usa (b)(4).Contact person: (b)(6).The defective control board was investigated at life cycle engineering in germany: the schmitt trigger on pin 13 of ic13 was defective.As a result, the signals on the ss_speed_m line can no longer be evaluated and the safety system has no information about the speed of the drive.For this reason the error head is displayed at a speed of 1000rpm and the drive stopped.This error is most likely due to the lugging in or unplugging of the pump head while the console is switched on.This failure is most likely due to hot plugging the rotaflow drive head.A supplemental medwatch will be submitted after new information has been received.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Internal reference: (b)(4).Autonumber: (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).

Event Description

Internal reference: (b)(4).Autonumber: (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7439940
• MDR Text Key: 106014349
• Report Number: 8010762-2018-00138
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2018

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 CONSOLE
• Device Catalogue Number: MCP00702697
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 04/03/2018
• Supplement Dates FDA Received: 07/11/2018; 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1