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

Model Number ROTAFLOW CONSOLE

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); No Flow (2991); Noise, Audible (3273)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was on v/v using rotoflow on free mode.Tt was free mode and medical staff states this is the only mode they utilize.They rolled the patient and immediately triggered a pump stop with the message reading ¿error¿ accompanied with an audible alarm they could not silence.Pump at this time had zero rpms and they were unable to remedy the alarm and unable to resume flow.Had to initiate emergency vent settings and went immediately to the hand-crank.Patient's sa02 dropped to 50%.Within 5 min of the pump stop, therapy was re-initiated using a different console.As of this am, patient is stable on new machine and no further issues reported.Internal reference: (b)(4).

Manufacturer Narrative

The rotaflow unit was returned to the depot in (b)(6) for further investigation.The service technician could not duplicate customer complaint.According to the service report the unit operated for five days without issues.All operating modes and warm and cold starts were tested.The service technician inspected the pcb´s, cables and safety check as per the service manual and the rotaflow device passed all test.

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: 7286195
• MDR Text Key: 100774297
• Report Number: 8010762-2018-00066
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• 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: 701051696
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2018
• Date Device Manufactured: 06/01/2015
• 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