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

Model Number 701043292 - ROTAFLOW ENGLISH/US US-PLUG

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the rotaflow had an error alarm.According to the summary report (b)(4) (dated (b)(6) 2020) the technician could not duplicate the error.Additionally the lemo cover was missing and the connector was loose.He replaced only the lemo rotaflow drive master connector.After that the unit was fully checked by the technician and passed all functional and safety tests.The reported failure could not be confirmed due to the fact that the technician could not duplicate the error.Thus a most probable root cause could not be determined.The failure occurred during service in the repair center.Du to this a relationship between the device and the complaint is given.The occurence 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 cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

A rotaflow drive master port for the rotaflow drive displacement/separation was reported.There was a note on the unit that stated there was an error alarm.What type of alarm was not reported.No harm to patient was reported.(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: 9617233
• MDR Text Key: 177995210
• Report Number: 8010762-2020-00021
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device 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: 701043292 - ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 70104.3292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse