MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

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

Device Problems Coagulation in Device or Device Ingredient (1096); Pressure Problem (3012)

Patient Problem Death (1802)

Event Date 07/13/2020

Event Type  Death  

Event Description

Customer had a (b)(6) kg, cdh, post-repair patient on ecmo.She had been on for 4.5 weeks.We did a circuit change on 7/13 due to increasing delta p (membrane had clotted of on the previous circuit due to a large clot breaking loose post pump head and occluding the oxy inlet).The delta p on the new circuit was 15-20mmhg, 48 hours in, the delta p acutely increased to 40 then began quickly increasing by 1mmhg about q5 minutes.We changed the membrane on 7/16 at 0100, at 2200 the delta on the new pedi was again 90 and climbing, we changed to an adult oxy.On 7/18 (around 0500, same thing, quick increase (double) of the delta p, and continued fast increase.Changed the oxy again, back to a pedi, at 2100, had to change again and then on 7/19 at 0700 was change again.All of them had the appearance as seen in the photos.The rest of the circuit was clean, not even clot at the connectors.Her antixa was 0.22-0.35, fibrinogen >300, at3 60-90, d-dimer had been >20 on 7/16, but decreased to 15, 11, 8 on subsequent days 7/17, 7/18, and 7/19, her appt was 50-90.She did receive 20ml/kg of platelets each day, as her platelet goal was >150 (i know!) and she received prbcs 3 times during this 4 day stretch.Her pfh increased from 100 to 170 over the 4 days.Patient expired, but according to the customer, this was not due to the circuit changes.(b)(4).The quadrox-id adult will be handled under complaint record# (b)(4), emdr# (b)(4).

Manufacturer Narrative

All involved oxygenators were disposed by the customer because as they stated: "we do not feel that the product was functioning abnormally, we are seeking to understand the conditions that could have led to the need for oxygenator replacement." a medical review was performed by manager medical affairs on (b)(6) 2020: despite the administration of heparin, according to the documentation provided, the patient¿s ptt levels were maintained close to a normal level (29-47) rather than the recommended 1.5 ¿ 2.5 times the normal value anticipated during ecls support.Although no thrombus or clot was visible within the circuit, elevated d-dimer levels may be indicative of a clot burden, whether located within the ecls circuit, or elsewhere in the patient¿s vascular system (i.E.Deep vein thrombosis, pulmonary embolism).While the administration of blood products during ecmo are frequently necessary, blood products containing procoagulative elements (e.G.Platelets) and may serve to accelerate the coagulation cascade, resulting in unexpected results in the extracorporeal circuit.During the period of frequent exchange 7/13-7/19 the patient reportedly did receive platelets daily, as well as three units prbcs.Per further inquiry, detail was provided that an in-line hemofilter was used for slow continuous ultrafiltration (scuf).This may have served as a source for further hemolysis or thrombus formation contributing to the need for the final two oxygenator exchanges.Elevated plasma free hemoglobin can be indicative of hemolysis and notably the patient¿s levels were elevated during the four days of this complaint¿s examination period.Elevated plasma free hemoglobin levels for patients on ecmo may be indicative of a clot burden or buildup within the ecmo circuit.It was noted by the customer that the patient¿s pfhb levels were elevated (100-170) the four days this complaint addressed.It is likely both the patient¿s acute illness, transfusion history, length of therapy and pro-thrombotic state that may have all contributed to the events.Thus the issue could be confirmed but no product related malfunction.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.

Event Description

Affected lot#70134796, 70134798, 70133848, 70137076, 70136605, 70134796.Complaint id:(b)(4).Note: the quadrox-id adult will be handled under complaint record#(b)(4), emdr#(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 10361415
• MDR Text Key: 201514400
• Report Number: 8010762-2020-00240
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• 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: 701050330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 2 MO
• Patient Weight: 3