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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

The reported failure "clotting outlet side" occurred during the transport of the patient.The patient was infected with covid-19.Covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.Due to the high risk of spreading the sars-cov-2 virus outside the healthcare environment, a technical investigation of this hls set is not possible as the laboratory of maquet cardiopulmonary (b)(4) is not suitable for who risk group 3.Furthermore, no external laboratory could be found that could carry out the investigation on our behalf.The clotting outlet side is visual on the provided picture and could be confirmed.As the failure is clearly visible in the pictures the failure could be confirmed.A similar case was already investigated under complaint #: (b)(4) on 2020-06-05: as stated in the investigation report of ot # (b)(4) clots could be found inside the oxygenator.The most probable root cause for the increased pressure drop are clots in the oxygenator leading to a blockage, and thus an extension of the diffusion path lowering the oxygenating performance.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4), v26) following causes could lead to coagulation: de-airing luer lock connection too loose.Air remains in or enters the circuit ; hemostasis; air or blood remains in luer lock access port; too low anticoagulation; too low at level, effect of heparin is too limited; protamine sulfate enters the hls set; administration of substitution of congealable substance such as plateles; (consumption) coagulopathy; thrombocytopenia.Device history record (dhr) was performed, and there were no references found, which are indicating a nonconformance of the product in question.The reported failure "clotting outlet side" occurred during the transport of the patient and could be confirmed.The occurrence rate was calculated for the reported issue 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 cardiopulmonarys trending program, and additional investigations, or corrections will be implemented in case of adverse trending.

Event Description

It was reported from a customer from poland that during the transport of the patient with implanted ecmo-cardiohelp-i + hls, the hls module have clotted.The standard procedure of filling the system was used (1500 ml nacl + 5000 international units of heparin).Parameters after implantation of the ecmo system: part: 88 mmhg, p ven: - 78 mm hg, p int: 124; delta p: 36.After 20 min of procedure (during transport of ambulance of the patient to ecmo center).Appeared an increase pressure inside oxygenator, and increase delta p value, and the same time decrease blood flow, deficiency gas exchange.The hls set was replaced with a new one.No indication of actual or potential for harm or death reported.Patient (b)(6) y old diagnosis: covid -19.Complaint id: (b)(4).

• Brand Name: TUBING SET
• 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: 11054229
• MDR Text Key: 223164783
• Report Number: 8010762-2020-00449
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 70144818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR