MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDI; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/25/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer report that during treatment with a quadrox-id pedi the flow dropped and was not able to be increased again.Patient expired.See detailed description provided by customer below: "patient (b)(6), with juvenile mielomonocytic leukemia, coagulopathy, possible aspiration pneumonia, hepatosplenomegaly was admitted on (b)(6) due to hypoxemic hypercapnic respiratory insuficiency.Bw 6 kg.Because of hypoxemic respiratory insuficiency unresponsive to conventional and inconventional mechanical ventilation, he was put on ecmo on (b)(6) at 21.52.V-a ecmo (vascular accesses: aci dex 8 fr, vjid 10 fr), mv 0,6l/min 3810 rpm, sweep gas 600-700ml/min, fio2 0,5.Spo2 right hand 99-100%, nirs brain 56, kidney 65.The first 12 hours act was around 130, after receiving antitrombin iii and increasing heparin infusion, it was in normal range 160-180.He was receiving plasma and thrombocytes due to thrombocytopenia.On (b)(6) at 12 am there was hypotension, with elevated rpm and additional supplementation of fluids (thrombocytes, ffp), we could not achieve adequate blood flow through ecmo.We are enclosing the ecmo protocol.The heart us showed increased right atrial size.Cardiovascular surgeon tried to optimize the position of the venous cannula, due to the assumption of inoptimal cannular suction; afterwards, he also changed the cannula.We are enclosing the reanimation protocol.Therapy: antibiotics.Piperacilin+tazobaktam (piperacilin/tazobaktam mylan 2 g/0,25 g razt.Za inj./inf.)  600 mg / 3 ml.Vankomicin (vankomicin kabi 1 g pra`ek za konc.Za razt.Za inf.)  125 mg / 2,5 ml.Citostatics: azacitidin (azacitidine accord 25 mg/ml pra`ek za susp.Za inj.Viala 100 mg 1x)  20 mg / 0,8 ml (3 doses).Citarabin (ara-cell 100 mg injektion viala 5 ml 10x)  20 mg / 1 ml (3 doses).Fludarabin (fludara 50 mg razt.Za inj./inf.Viala 5x)  6 mg / 0,24 ml (1 dose).Deksametazonfosfat (dexamethason krka 4 mg/1 ml razt.Za inj.Ampula 1 ml 25x) odmerek 1 mg / 0,25 ml  cvk  2x na dan.Anticoagulants: antitrombin (kybernin p 500 i.E.Razt.Za inj./inf.Viala 10 ml 1x)  300 i.E./ 6 ml.Humani fibrinogen (fibrema 1 g pra`ek za razt.Za inj./inf.)  300 mg / 15 ml.Heparin for the target level 160-180 (up to 52 iu/kg/hour) tranexamic acid 1 dose.Inotrops: dopamine and adrenaline".Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the flow of a quadrox-id decreased.The getinge product was directly involved with the reported event and failed to meet its specifications.The device was being used for treatment.The hls module was investigated in the getinge laboratory on (b)(6) 2021.Upon rinsing of the oxygenator large clots was detected and high pressure was needed to achieve flow.During visual inspection and leak test no issue was noted.The production records of the affected quadrox-id module ((b)(4)) were reviewed on 2021-03-04.According to the final test results, the oxygenator with the serial# (b)(4) passed the tests as per specifications.Production related influences can be excluded.For further investigation a medical review was performed on 2021-04-23 with following results: while the active clotting time (act) appeared to be maintained between 150 and 200 seconds with an act of 160 seconds at the time of the event, it was mentioned in passing that the act was 130 seconds for the first 12 hours of support despite the administration of antithrombin 3 (atiii).Additionally, there appeared to be a period of about three (3) hours where the act was below 100 seconds.This act range likely contributed to exacerbation of the clotting cascade.Recommendations for act management during ecmo is a range of 180 to 220 seconds.Further transexamic acid was administered to the patient during this case.While transexamic acid may be administered to manage coagulopathies it may also promote clotting, as an antifibrinolitic, within an extracorporeal circuit where acts are managed at a lower level than traditional cardiopulmonary bypass.Last, while the administration of blood products during ecmo are frequently necessary, some blood products contain procoagulative elements (e.G.Platelets, clotting factors, etc.) and may serve to accelerate the coagulation cascade, resulting in unexpected results (viz.Clotting) in the extracorporeal circuit or during extracorporeal support.As explained by the attending physician, the hepatomegaly and splenomegaly with ascites may have been an ¿anatomical¿ rationale (root cause) for the reduction in flow experienced in this case.Based on this the reported failure could be confirmed but no product related malfunction.No correlation between a malfunction of the getinge product and the reported death could be confirmed.Following probable root causes were determined leading to the reported failure: -insufficient anticoagulation.-administration of transexamic.-administration of blood products.-patient condition (anatomical resictance due to hepatomegaly and splenomegaly).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

(b)(4).

• Brand Name: QUADROX-ID PEDI
• 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: 11435477
• MDR Text Key: 238364119
• Report Number: 3008355164-2021-00005
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 701047041
• Device Lot Number: 70144395
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2021
• Distributor Facility Aware Date: 04/23/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2021
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 6 MO
• Patient Weight: 6