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

Model Number RF-32#CENTRIFUGAL PUMP WITH FLOWPROBE

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problem Hematuria (2558)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

Return of the affected product and further patient and perfusion data was requested but still pending.A follow-up emdr will be submitted when additional information becomes available.

Event Description

During ecls treatment hematuria was noted and the rf-32 made unusual noises.After the centrifugal pump was replaced it was noted that the bearing ball was dislocated.Complaint: (b)(4).

Manufacturer Narrative

During treatment hematuria was noted and the rf-32 made unusual noises.After the centrifugal pump was replaced it was noted that the bearing ball was dislocated.The affected centrifugal pump was investigated at the getinge laboratory on 2022-04-22.No defects or abnormalities were detected by visual inspection.The bearing ball was not in the bearing socket and was loose between the rotor and the lower part of the housing.No blood clots were found in the pump.Thus the reported failure could be confirmed.The most probable root cause could be determined as the following: -overpressure leads to expansion of the pump.This can cause the gap between the bearing socket and the bearing seat in the rotor to open up due to increased bearing gap between the rotor and the upper part of the housing.Loosening of the bearing ball would be possible.-the bearing ball was incorrectly placed during the manufacturing process.In order to adress this a non confirmity was initiated to investigate further.Furthermore mcp production was informed about the investigation results and a retraining of the affected process was performed.The reported failure was also evaluated by the getinge medical affairs on 2022-05-10 with the following outcome: a production-related origin (in the context of this complaint) cannot be ruled out.An application/use error may also be the root cause of the failure.It is possible that during set up and priming, the rf-32 was subjected to excessive pressure (1.5 x maximum specifications), or a high oscillatory pressure.Excessive pressure(s) can theoretically deform the housing and displace the bearing ball resulting in the reported failure mode as per the investigation results in the getinge laboratory.The deviation found during investigation (bearing ball displacement) typically should be readily apparent during the system priming sequence as described in the the instructions for use (ifu).As per the ifu), flow set points of 3-4 litres/minute are required during the priming sequence for proper priming, de-airing and as part of a functional check.Flows at 3-4 litres/min with the concurrent failure mode as reported and tested result in excessive noise and difficult flow adjustment.Although a noise was reported, difficulty setting flow was not reported in the complaint and not noted during therapy based on follow-up questionnaires.Despite the indeterminate root-cause, the likely root-cause was possibly user-associated.The disposable elicited an atypical noise during priming, even at the low flows, that was noted during priming and therapy.As a secondary observation the displacement of the bearing and rotor may be associated with increased hemolysis and hemoglobinuria (as opposed to hematuria as reported).Although a differential diagnosis of hemoglobinuria versus hematuria was not provided in the report, the pump failure that was confirmed may have lead to pump-induced hemolysis and hemoglobinuria.High plasma free hemoglobin (pfhb) levels will likely result in excretion via the kidneys during therapy.Hemolysis leading to high pfhb are associated with renal injury and potential multi-organ failure (omar, et al., 2015).The report did not elaborate on the reported hemoglobinuria (called hematuria in the narrative).Additionally, plasma free hemoglobin levels were not provided by the clinic.The prompt replacement of the rf-32 with a new blood pump was reported to be corrective and therefore supports the above conclusion that the event had induced increased hemolysis during the course of therapy.The clinical team assessed and intervened, and the rf-32 under investigation was removed and replaced with an alternate blood pump.The patient was successfully weaned from ecmo and no further sequelae were reported in the complaint.The production records of the affected centrifugal pump with the production lot# 3000198756 were reviewed on 2022-05-11.Following steps are performed according to the bop with a 100 % inspection: assembling housing, functional test.According to the final test results, the rf-32#centrifugal pump with the serial# (b)(6)passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.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: CENTRIFUGAL PUMP WITH FLOWPROBE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 13384813
• MDR Text Key: 284620466
• Report Number: 8010762-2022-00023
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K08470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RF-32#CENTRIFUGAL PUMP WITH FLOWPROBE
• Device Catalogue Number: 701005308
• Device Lot Number: 3000198756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 14 KG