MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH VENOUS HARDSHELL CARDIOTOMY RESERVOIRS; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number HQV 13122#QUADROX MEMBRANE SET

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Fault on the circuit: abnormal deposits in the cardiotomy tank.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh was requested the product back for investigation on 2019-07-25.Product was received on 2019-08-01.Visual inspection was performed on (b)(6) 2019.The returned reservoir was contaminated hence it was submitted to a cleaning process using sodium hypochlorite as per local procedure lv 205.After cleaning, no deposit or existing coating could be seen.However, before this cleaning process also no coagulation or deposit could be recognized.Only small clots could be seen.The reported failure was identified as part of the current risk management file (dms #(b)(4)) and the most possible root cause is associated to design and instruction for use.These issues are mitigated with design specifications and instruction for use warnings and/or precautions.The information was shared internally with r&d engineer and discussed with r&d engineers and therapy application manager.It was concluded that, the pictures allow no definite statement.It is not possible to determined exactly the deposits, if they are lipids or fibrin deriving from the blood of the patient.The appearance of the reservoir is most likely a result of handling during ecc.The caked blood in the upper area could originate from sucker blood exhibiting an insufficient anticoagulant treatment.Instruction for use mitigation: absence of adequate anticoagulation results in clotting within the system and consequently occlusion of the extracorporeal circuit and the patient circuit.This can lead to inadequate patient support, thrombus formation, hemolysis, hemostasis and ischemia in the patient.Weigh up the benefits of extracorporeal circulation against the risk of systemic anticoagulation.Use anticoagulants; e.G., heparin or argatroban.Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).The act should not fall below 480 s for all components.Based on this failure could not be confirmed.The most probable cause is use error absence of adequate anticoagulation.In addition, device history records for lot 92252156 and for semi-finished reservoir lot 92269611 have been reviewed on 2019-08-29.There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Trend search was performed on 2019-08-29.2 additional complaints were recorded in the last 12 months which appears reported issues are similar.(b)(4).Due to this information no systemic issue could be determined.The reported failure did not contribute to death or serious injury.In addition at this time it cannot be concluded that this is a systemic error.No further actions are required.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

Compliant # (b)(4).

• Brand Name: VENOUS HARDSHELL CARDIOTOMY RESERVOIRS
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8784136
• MDR Text Key: 150971654
• Report Number: 8010762-2019-00206
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• PMA/PMN Number: K090534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2020
• Device Model Number: HQV 13122#QUADROX MEMBRANE SET
• Device Catalogue Number: 70104.6406
• Device Lot Number: 92252156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 10/21/2019
• Patient Sequence Number: 1