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

Model Number 701022161 - ROTAFLOW DRIVE UNIT, BLUE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Device not returned not eval.

Event Description

Head error.Complaint# (b)(4).

Manufacturer Narrative

The initial failure description was a "head error".The service order has not been received despite several requests.This complaint will be closed without the service order.Therefore it cannot be assured in which technical status this device is currently.This complaint will be reopened and appropriate actions will then be taken if the service protocol is received and contains any further relevant information.Thus the reported failure could not be confirmed and a most probable root cause could not be determined.Due to missing information despite several requests it is unknown if the device was used for treatment and diagnosis.As explained above it cannot be confirmed if a relationship between the device and the complaint is given.The occurrence rate is below the acceptance rate, thus no remedial action required.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : 3221.

Event Description

Complaintnumber: (b)(4).

Manufacturer Narrative

The initial failure description was a "head error".The complaint was closed on 2020-01-10 due to lack of information.Reopend on (b)(4) because of receiving the emtec investigation results.The effected rotaflow drive with the serial number (b)(6) was shipped to germany under rma#39221 for repair to the manufacturer emtec.Incoming goods in rastatt on 2019-10-07.--> functional test in rastatt on 2019-10-08 head error confirmed.Send to emtec on 2019-10-14.Back from emtec on 2020-02-13.Functional test in rastatt after emtec on 2020-02-13.Outgoing goods on 2020-02-13.According to the service report rma2019-10247 from emtec the failure could be confirmed.The electronic platine mc1 and mc2 was detected as defective.Additional work was performed: knurled nut, pressure piece, electronic parts, flowsensor and sealing replaced.All defective parts were replaced.The rotaflow drive passed all tests.This work was performed on 2020-01-29.Thus the reported failure could be confirmed and a most probable root cause could be determined as aging according to emtec.The rotaflow drive was tested in rastatt according to current valid service protocol.Furthermore most probable root causes for the reported failure "head error" are determined as follows: 1.The head error is caused by the hot plug.When device is in operation and the power plug is plugged in or out.And this leads to a damage at the control board of the rotaflow.2.The head error follows by the sig error.This is when the ultrasonic crème is applied to the flow bubble sensor.Then the centrifugal pump is causing backflow and this leads to the head error.3.The head error is also caused by shaking the drive.This is when the motor (which is controlled by the optical tacho) is not blocked when adjusting to 0 then it could lead to error when slight shaking.The motor could then slightly rotate.4.The head error can be caused by connection issues between the console (rfc) and the drive (rfd).This is when the cable connection is disturbed by defective pins.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manuel, mcv-ga-10000703-de-11 contain detailed descriptions to prevent an ¿error head¿.Due to missing information despite several requests it is unknown if the device was used for treatment and diagnosis.The device was directly involved thus a relationship between the complaint and the device is given.The occurrence rate is below the acceptance rate, thus no remedial action required.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaintnumber: (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8938682
• MDR Text Key: 182552275
• Report Number: 8010762-2019-00265
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

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: 701022161 - ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 01/28/2020; 02/13/2020
• Supplement Dates FDA Received: 01/09/2020; 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1