MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PAD.O.FILT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT

Device Problems Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Manufacturer Narrative

Return of product and patient data were requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that they needed to change out emergently (within 24-36 hours) a quadrox-id pediatric due to high transmembrane pressures that indicate that there is a large amount of blood clot present inside the oxygenator.When this happens it affected the ability to maintain ecmo flow to the patient.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the transmembrane pressure of a quadrox-id pedi increased during treatment leading to a decreased flow.This complaint ((b)(4)) is associated with three other complaints ((b)(4)reported under 8010762-2021-00118, (b)(4)reported under 8010762-2021-00119,and (b)(4) reported under 78010762-2021-00120) with identical circumstances.All the oxygenators (pediatric quadrox-ids) mentioned in the context of this complaint (and the associated complaints) were used with patients on whom ecmo/ecls was deployed.In all cases, the oxygenators required emergent replacement within 24-36 hours secondary to high transmembrane (delta) pressures.The assumption of the clinical staff was that high transmembrane pressures was indicative of clot presence (frank clot) with the oxygenator.As a result, the flow through the oxygenators was reduced.The oxygenator was not available for technical investigation in the getinge laboratory.For further investigation getinge medical experts performed a medical assessment on 2021-05-18 based on the information provided by the customer: the customer stated sodium heparin was administered during two cases with the antixa maintained in a range of 0.5 to 0.7.This range was well within the recommended antixa range of 0.3 to 0.7.One of two cases was a post-operative cardiothoracic patient and the other case was a neonate with persistent pulmonary hypertension of the newborn (pphn).In both of the cases mentioned above, the pediatric quadrox-id required replacement within 24 to 36 hours of the start of product use.Replacement (change-out) was predicated on 1) the increase in rpms to maintain flow and 2) a rapid increase in delta pressure/transmembrane pressure from 10 to over 100 within a few hours.In both cases, the circuit appeared to be ¿clean¿.The assumption is that this implied the circuits were free of visible clot.Additionally, the ¿faceplates¿ were free of visible clot.It is assumed that by ¿faceplate(s)¿ the user intended the clear venous pre-chamber of the pediatric quadrox-id.There is no mention of visible clot in the clear arterial post-chamber.According the customer, the usual flow when using the pediatric quadrox-id (as a matter of clinical practice) is ordinarily above 200 ml/min.It may be inferred from the customer response that the flow may (occasionally) be below 200 ml/min.It may be noted that the recommended minimum operating flow for the pediatric quadrox-id is 200 ml/min according to the product instructions for use.2 a centrifugal pump is the pump of choice for this institution and for these cases.No details were divulged with respect to either the manufacture or the size (adult or pediatric) of the centrifugal pump used in these cases.The customer mentioned that there is no knowledge of similar events (expressed in this complaint or its associated complaints) previous to this complaint.Little is known about the anticoagulation regimen, status, or values seen during support (i.E.Apart from the antixa values).No information has been supplied in terms of free plasma hemoglobin, d-dimers, platelet function tests, medications administered, or banked blood products administered.However, two possible root cause may be considered in light of the information that is known: -oversized (adult) centrifugal pump compared to the pediatric oxygenator pump newer studies have demonstrated that some adult centrifugal pumps show a decreased hydraulic efficiency at lower flows (viz.Flows below 2.0 lpm and 1.0 lpm) which results in higher incidence of in vitro normalized index of hemolysis.Whether a possible increase in hemolysis, due to an oversized centrifugal pump (with respect to pediatric application), affected the pediatric quadrox-id performance is difficult to determine without an complete examination of the actual membrane.-lower than recommended blood flow using a lower than recommended flow through an oxygenator may cause shifting in the flow pattern of a membrane package to favor some areas while excluding or minimizing other areas of a membrane.The exclusion or minimization of some areas within a membrane package may create a condition that favors clotting within those areas of low to no flow.As the customer reported that the issue occurred more often than before the occurrence rate of the failure "clotting, high transmembrane pressure" was checked for the last five years for the product group quadrox-id pediatric (performed on 2021-05-18).No trend or systemic issue could be determined.Based on the investigation results no product related malfunction or systemic issue could be confirmed.The occurrence rate was calculated for the reported failure 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.H3 other text : 4114.

Event Description

Complaint id: (b)(4).

• Brand Name: QUADROX-ID PAD.O.FILT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11435335
• MDR Text Key: 242778657
• Report Number: 8010762-2021-00152
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
• Device Catalogue Number: 70105.0330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Patient Sequence Number: 1