MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH ROTAFLOW CENTRIFUGAL PUMP SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Catalog Number 70104.3292

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/13/2019

Event Type  malfunction  

Event Description

At 0954: received phone call that the pump had a "sig" reading.The pump was reading sig, but still had flow (3480 rotations per minute (rpm) and 4.6lpm liters per minute (lpm)).Family was present, and i indicated to nursing that i would have to briefly interrupt extracorporeal flow to apply lubricant to the flow meter, which would disengage the active alarm.I clamped the arterial and venous lines, turned rpm to 0, removed pump from centrifugal head, applied lubricant to the flow meter, and reinserted pump head into the centrifugal unit.Upon trying to increase rpm's, the pump then read "error!", so i did a hard reset, turning the console off and back on, reset the rpm to 0 and restored rpm back to meet patients' needs, removed my arterial and venous clamps and restored flow to the patient.The patient tolerated the entire event without any deterioration.At 1006am: i made my way back to the perfusion pump room, and as i did the patients nurse called to say that the pump was alarming "temp error".I took this to mean the pump was overheating and instructed them to start hand cranking while i got another console over to the room.Upon arrival, nursing and respiratory were hand-cranking the extracorporeal membrane oxygenation (ecmo) console and the patient was stable.I re-engaged the centrifugal pump to the original console pump head, turned the machine off, then back on and it read "error" and i made the decision to change over to the new console.I started the new console, zeroed the rpm, nursing helped me engage the pump to the centrifugal head and i restored flow to 4 lpm.With the assistance of nursing, i then changed over the oxygen and medical air lines to the new unit and put the patient a 2lpm of sweep gas and 100% fraction of inspired oxygen (fi02) and had the nurse let the md know what had happened and that i would be leaving the sweep and fi02 at those levels until i could obtain and post-oxygenator gas to ensure it was still oxygenating efficiently and that the patient had not decompensated.The oxygenator was then placed on the new console and the new console was plugged into the appropriate red emergency outlets and taken off of battery power.I completed a post oxygenator blood gas, which was satisfactory and told nursing that i recommended doing a patient blood gas at 11am, and if satisfactory to the md we could return the sweep and fi02 back to pre-event settings.At 11am a patient blood gas was conducted, which all parties (perfusion, nursing, and md) were satisfied and the settings were returned to 1lpm of sweep and 50% fi02.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8526675
• MDR Text Key: 142337553
• Report Number: 8526675
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 70104.3292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA