MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HQV 50600#

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up mdr will be submitted when further information becomes available.4115.

Event Description

It was reported that the transfusion of platelet concentrate and ecmo discontinuation occurred.Patient entered réa polyvalente for ards with massive aspiration and severe acute lithiasic pancreatitis.Failure to restore correct hematosis despite ventral decubitus and ineffective no: decision to place veno-venous ecmo.Patient was on ecmo between (b)(6) 2023.Major and progressive thrombocytopenia up to 18g/l ((b)(6) 2023) under ecmo requiring a transfusion of platelet concentrate elimination of hit on negative anti-pgf4 antibodies and negative elisa pharmacovigilance evokes a potential imputability of piperacillin tazobactam but also wonders about the potential imputability of ecmo (description of thrombocytopenia under ecmo in the literature).Piperacillin tazobactam was subsequently reintroduced without further thrombocytopenia.Complaint #: (b)(4).

Manufacturer Narrative

Description of the facts: patient entered réa polyvalente for ards with massive aspiration and severe acute lithiasic pancreatitis.Failure to restore correct hematosis despite ventral decubitus and ineffective no: decision to place veno-venous ecmo patient on ecmo between (b)(6) 2023 and (b)(6) 2023.Major and progressive thrombocytopenia up to 18g/l ((b)(6) 2023) under ecmo requiring a transfusion of platelet concentrate elimination of hit on negative anti-pgf4 antibodies and negative elisa pharmacovigilance evokes a potential imputability of piperacillin tazobactam but also wonders about the potential imputability of ecmo (description of thrombocytopenia under ecmo in the literature).Piperacillin tazobactam was subsequently reintroduced without further thrombocytopenia.Consequences: transfusion of platelet concentrate and ecmo discontinuation.There is no actual harm to any person was reported.The product is not available for investigation.The lot number of the affected be-hqv 50600 could not be provided by the customer.Therefore, dhr (production records) review could not be performed.Several attemps to reach out the customer for further clarification in association with the complaint was not successful.Getinge medical affairs assessed the complaint based on the available information: the customer complaint report and available correspondence was carefully reviewed.The paucity of information related to patient history and management in the correspondence make the review challenging.The patient¿s primary diagnosis is associated with a very complex pathophysiology (acute pancreatitis, ards, and aspiration).Based on the primary diagnosis of acute pancreatitis, there is evidence in the literature of platelet activation and consumption.Acute pancreatitis has also been reported rarely in association with thrombotic thrombocytopenic purpura (ttp).The clinical management and clinical pathways associated with pancreatitis can be very complex but are often associated with a severe systemic inflammatory response (sirs), multi-organ failure, and disturbances in hematopoiesis, including function, production and total platelet count.The manifestation described in the literature are independent of vv ecmo support.The appended hitt assay and elisa study provided by the clinic appear to rule out hitt as a possible root cause.The hitt assay was negative.The differential diagnosis for hitt is well described by the french working group on perioperative haemostasis (groupe d¿interet en hemostase perioperative [ghip]) and the french study group on thrombosis and hemostasis (groupe d¿etude sur l¿hemostase et la thrombose [gfht], in collaboration with the french society of anaesthesia and intensive care medicine (societe francaise d¿anesthsie et de reanimation [sfar]).The application of the algorithm is beyond the scope of clinical information available in the complaint and the assessment, but does provide a systematic peer reviewed method of assessing the occurrence of thrombocytopenia in complex presentations during patient care.Further, neither the gruel article (gruel, et al., 2020) nor the reproduction of the algorithm are intended to conflate medical advice per se.They are, intended to propose a possible root cause to the clinical event explained in the complaint narrative despite lack of clinical details.Based on a review of the available information it appears that the severe thrombocytopenia is unrelated to the disposable.No malfunction of the device was reported in terms of essential performance (oxygen transfer and carbon dioxide removal).The device was not available for investigation to further assess a potential root cause.A review of the last 24 months trend reports for device complaints found no similar event or association with device therapy when evaluating a root cause in relation to a negative hitt assay (anti pf4 antibody testing).The application of the device does not appear to be associated with a use error.The event reported appears more likely related to complex patient co-morbidities as suggested above and not related to the device under review.This complaint was found as a single event in the database during the reviewed period.The occurrence rate was calculated for the reported failure and product 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 #: (b)(4).

• Brand Name: TUBING SET
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• 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: 16545426
• MDR Text Key: 311330853
• Report Number: 8010762-2023-00136
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HQV 50600#
• Device Catalogue Number: 701026718
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1