MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I ADULT WITH VENOUS HARDSHELL CARDIOTOMY RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number QUADROX-I ADULT HMO 70000 + VHK 71000

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Death (1802)

Event Date 03/14/2014

Event Type  Death  

Event Description

On (b)(6) 2014 at the (b)(6) in the (b)(6) it was reported that the quadrox-i adult hmo 70000 + vhk 71000 oxygenator from lot number 70095062 was not oxygenating during a perfusion procedure.At first, the oxygenator performed well but after the patient was transfused with rbc, ffp and trombocytes, the oxygen saturation (po2) was very low (7.2 kpa) and the ph of the blood was 7.02 and lactate levels were high.The patient was connected to a cardiohelp and moved to the icu.It was reported that later on the patient died in the icu.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The returned sample was analyzed by pressure testing in the laboratory and the exchange performance of carbon dioxide was 36 ml/l which is below the required minimum level of 38 ml/l at maximum flow of 7 l/min.This can be explained from the clotted area seen in the oxygenator after receiving the device for investigation.The clotted area acted as a barrier and prevented the blood from reaching the gas fibers and hence minimized the co2 transfer efficiency.In case of the described emergency treatment with a high rate of transfusion (rbc, ffps and thrombocytes) the risk of clotting increases extraordinary in any kind of extracorporeal support (ecls) and contact to foreign bodies.An anticoagulant, like recommended while ecls was not possible in this case and so clotting might have been unavoidable.(b)(4).

• Brand Name: QUADROX-I ADULT WITH VENOUS HARDSHELL CARDIOTOMY RESERVOIR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4944812
• MDR Text Key: 16562536
• Report Number: 8010762-2015-00474
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2015
• Device Model Number: QUADROX-I ADULT HMO 70000 + VHK 71000
• Device Catalogue Number: 70106.4524
• Device Lot Number: 70095062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/14/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2014
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death