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

Model Number ROTAFLOW FRENCH EU-PLUG ICU

Device Problem Improper Flow or Infusion (2954)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Event occurred in (b)(6).It was reported that the customer has installed a pls circuit on the rotflow console.At over 3000 rpm, the flow reading window read 0.48l / min and blood visually was moving smoothly through the circuit.The customer has changed the pls circuit.The 2nd circuit, at more than 3000 rpm, the flow window displayed 0.5l / min and the blood visually advanced slowly in the circuit.The doctor decided to replace the second pls circuit with an eccor circuit.The rotaflow console has already experienced a bit rate reading problem.The customer now wants the intervention of a technician to check the flow reading of the rotaflow console.No indication of actual or potential for harm or death reported.Due to the exchange of the pls sets during use report in us is required.Complaint id: (b)(4).

Manufacturer Narrative

Event occurred in france.It was stated by the customer that they installed a pls circuit on the rotaflow console.At over 3000 rpm, the flow reading window read 0.48l / min and blood visually was moving smoothly through the circuit.The customer has changed the pls circuit.The 2nd circuit, at more than 3000 rpm, the flow window displayed 0.5l / min and the blood visually advanced slowly in the circuit.The doctor decided to replace the second pls circuit with an eccor circuit.The rotaflow console has already experienced a rate reading problem.The affected rotaflow console with s/n (b)(6) was investigated by a getinge field service technician.During the investigation by the technician on 2021-01-21 the reported failure could not be reproduced.However, ssu france stated that the most probable root cause could be determined as a misplaced cannula during treatment.The cannula was placed in a bad vessel and not in the right atrium.Based on these investigation results the reported failure "flow reading not correct" could not be confirmed.The review of the non-conformities has been performed on 2021-02-18 for the period of 2017-11-17 to 2021-02-18.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.The product in question was produced in 2017-11-17.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is 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: 11243090
• MDR Text Key: 229354072
• Report Number: 8010762-2021-00087
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW FRENCH EU-PLUG ICU
• Device Catalogue Number: 701051699
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2021
• Patient Sequence Number: 1