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

Model Number ROTAFLOW CONSOLE

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

(b)(4).During use, the rf unit displayed "ill.Err", which caused a pump stop.The unit was swapped out for another rf unit.No injury to the patient was reported.

Manufacturer Narrative

Maquet medical systems, usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).The device was investigated by a service technician.Work performed on 2018-03-16.Result of service order: (b)(4): complete repair with full calibration, functional testing and safety checks to factory specifications.Returned unit to customer.The failure could not be reproduced.The control board in question was requested for investigation on 2018-04-04 with rma#: (b)(4).After several questions the service technician confirmed that the control board was destroyed.According to email received on 2018-10-19 the ssu informed the dcu that the control board is not available for further investigation anymore.The determination of the root cause is impossible due to missing material.Thus the failure could not be confirmed.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.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that it is a systemic error.No corrective action is needed.

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: 7392177
• MDR Text Key: 104417561
• Report Number: 8010762-2018-00119
• 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
• Report Date: 10/23/2018

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: 701051712
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1