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

Model Number ROTAFLOW CONSOLE

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa 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.

Event Description

(b)(4).The rotaflow console (first) worked on the hl 20 and later stopped working no battery alarm was noted/observed, then swapped out pump to the next rotaflow (second) and would not run and then the third console was set to free and trouble had to set to arterial mode and continue case.They hand cranked for 30 minutes.No injuries occurred to the patient.

Manufacturer Narrative

The device was checked for the reported fault as per incident report notes and confirmed that no fault or issue could be found with the rotaflow and hl20 communications or the pump power on/off switches.No fault found ran rotaflow drive battery greater than 90 minutes and had no reoccurredence of "batt" error on the screen 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 this is a systemic error.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.A supplemental medwatch will be submitted if new information is received.

Event Description

(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
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6859007
• MDR Text Key: 86100957
• Report Number: 8010762-2017-00292
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K9918644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• 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: 701035242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1