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

Model Number 701022161 - ROTAFLOW DRIVE UNIT, BLUE

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

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

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the rotaflow drive cable got damaged.The reported failure could according to the service report (b)(4) by emtec, not be confirmed.They found another failure during testing/repair: error head and that the ild is defective.According to the service report (b)(4) from 2020-2-13 and the to the service report attached repair document from emtec, the device had an head error.After this information a new assessment of the reporting decision was made.And the new result is reportable.The failure head error can be confirmed.They were preparing the device for a patient transport between hospitals, which fits not the intended use environment.The intended use environment is according to the instructions for use 4.2 | en | 13 only within clinical institutions.The reported failure is responsible for this complaint according to the service report (b)(4) by emtec a root cause in this case could not be determined.But the most probable root causes for head error are: 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 creme 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, chapter 8.1.2 contain detailed descriptions to prevent an ¿error head¿.The occurrence rate 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 cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

It was reported, that the user were preparing to transfer the patient to another hospital, when one of the staff members accidentally forced the rotaflow drive cable into the master connector at the back of the rotaflow.This damaged one of the pins of the connection cable.(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
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 9717059
• MDR Text Key: 196773409
• Report Number: 8010762-2020-00067
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K991864
• 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
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1