MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00967621#RFD 20-973 ROTAFLOW DRIVE

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported from the us that during testing in the ssu repair the rotaflowdrive on a rotaflow console ran for about 20 hours at first then started giving signal errors, then would not run or show lpm at all and just has a set of dashes in the lpm window and puts the rotaflow into alarm.The unit doesn¿t show lpm rating when connected to the rotaflow unit.No patient was involved.Complaint id: (b)(4).

Manufacturer Narrative

The affected rotaflow drive is not repairable in the field.The rotaflow drive will be sent back under rma#39537 to germany for repair by the manufacture em-tec.Incoming in rastatt 2019-11-19 functional test in rastatt 2019-11-20 --> failure confirmed.Additional piece of mast holder missing.On closing assy the rubber is missing,on the cover a screw is missing and leakage of oil in rfd arm sent to em-tec 2019-11-25 functionaltest after emtec in rastatt 2020-02-05 outgoing goods 2020-02-11.According to the service report rma2019-10394 from emtec 2020-01-30 following work has bee done by the manufacturer of the rotaflow drive.The reported failure "unit doesn´t show lpm" could be confirmed by the manufacturer.Additional was detected on the drive that flowsensor has no amplitude (defective), piece of mast holder missing, handle of mastholder defective and the rubber foot on closing is missing.The flowsensor and the handle of the mastholder was replaced.Piece of mastholder and rubber foot on the closing newly installed.Rotaflow drive passed all tests.The probable root cause according to the manufacturer emtec for the reported failure "unit doesn´t show lpm" could be determined as aging/mishandling.The inspection in rastatt after the repair by the manufacturer emtec carried out.System test performed according to the current valid service protocol.The reported failure "unit doesn´t show lpm" occurred during repair by the ssu and could be confirmed.The device was directly involved in the incident.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9259875
• MDR Text Key: 200660951
• Report Number: 8010762-2019-00344
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

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: MCP00967621#RFD 20-973 ROTAFLOW DRIVE
• Device Catalogue Number: 701010875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/13/2020
• Patient Sequence Number: 1