MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number VKMO10000

Device Problem Occlusion Within Device (1423)

Patient Problems Hyperglycemia (1905); Thrombus (2101)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "this device was used on a neonatal patient, for a tetrology of fallot procedure.Pre-procedurally the patient had act of 600, during bypass 580 anf then at end of procedure 400+.Platelets were normal, no heparin given.Tubing set was blood-primed with no products added.During the case the volume dropped from 250ml by 50ml (which is normal) at which point the perfusion noticed a clot forming within the screen of the reservoir.The clot was of pasty consistency.There was no clot found on the arterial outlet or within the arterial filter.The hospital are not sure what caused the clot, but felt it necessary to report, nonetheless.Unfortunately the device was discarded at the end of the procedure.The procedure was completed normally, there was no effect to the patient, who was discharged normally from icu." (b)(4).

Manufacturer Narrative

(b)(4).The visual investigation of the received pictures showed that the reservoir shows clotting.The sample was discarded by the hospital.Clotting is a known phenomenon to maquet and has been thoroughly investigated in a previous complaints,4 additional complaints were recorded.Device history record of the lot has been investigated and no abnormality was found.An internal clinical assessment was performed based on the received complaint report.Though the device of complaint was coated clotting may occur when the perfusion takes a steady course over a longer period of time.When the preload and afterload conditions solely changes slightly and the suction/vent volume also maintaining steady.The initial act level was high but the report mentions that no additional heparin given.It is unknown what exactly 400+act mean and as a combination of a steady perfusion with a slightly low anticoagulation a promotion of coagulation could have occurred.The high activated suction blood probably increased the progression of the clotting.Furthermore the report states the volume dropped during the case and so the viscosity of the perfusate may have increased and also contributed to the clotting.It is not reported and remains unclear if not coagulatory substances,such as blood substitution products have been applied during the case,which likely could have promoted the finding.The photographs unveil significant filter thrombosis,but a conclusive assessment is barely possible.Even with more information from the hospital it is hard to determine.Taking the accessible information into consideration it is deemed to be not necessarily hence a sole device mal-performance.The exact root cause of the failure could not be determined.This data will be handled through a designated maquet trending process.

Event Description

(b)(4).

• Brand Name: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6311659
• MDR Text Key: 67228870
• Report Number: 8010762-2017-00037
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K141432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

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: 01/31/2018
• Device Model Number: VKMO10000
• Device Catalogue Number: 70105019
• Device Lot Number: 92187533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: 01/11/2017
• Supplement Dates FDA Received: 07/11/2017
• Date Device Manufactured: 02/01/2016
• 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