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

Model Number HQV 0605

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 05:00 pm (gmt-5:00) added by (b)(6) ((b)(4)): (b)(4).Maquet cardiopulmonary gmbh requested the product back for investigation but it has not yet been received.Investigation is still pending.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

Shortly after perfusion was initiated an increase in the delta p was noticed.Delta p increased during perfusion until shortly before aorta to a delta p of over 250-300 mmhg.Product was replaced.No clotting was noticed.(b)(4).

Manufacturer Narrative

Maquet (b)(4) received the product for manufacturer laboratory investigation.The product was flushed with water and visual inspected.No clotting could be found.Investigation is still on-going.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

(b)(4).

Manufacturer Narrative

The oxygenator was tested for its pressure drop performance regarding lv009.Thereby a pressure drop during maximum flow at a blood-gas-ratio 1:1 max.100 mmhg was performed.A pressure drop which was not according to our specifications could be observed during testing.As a matter of fact the integrity of the softline coating is not guaranteed after the disinfection process which involves a very aggressive solution, therefore the probability of micro clotting inside the oxygenator rapidly increases, and consequently high pressure drop could be observed in this case.Investigation is still in process a supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

(b)(4).

Manufacturer Narrative

As the oxygenator did not pass the pressure drop test, it was returned to the complaint laboratory for further examination.The oxygenator was sawn open to examine its internal structure and condition, and to be able to examine the filter pads for any signs of damage, blue marks or other anomalies, and to check that the correct number of filter pads were used in manufacture of the product.The test results were as follows: the filter pads did not show any signs of damage or other anomalies.There were no blue marks on the filter pads.There were 76 filter pads on the gas side of the oxygenator, as specified.There were 23 gas filter pads on the water side of the oxygenator, as specified.There were 22 water filter pads on the water side of the oxygenator, as specified.It was concluded from the examination of the oxygenator that it appeared to be in accordance with specification.A device history record of the affected lot has been investigated and no abnormality was found.However, a definitive root cause for the increase in the delta p measurement cannot be determined, as the differential flow measurement and vascular resistance can be affected by a number of factors such as patient condition and clinical application, and the disinfectant used in the decontamination laboratory could have affected the pressure drop performance of the oxygenator.It is therefore not possible to reach a definitive conclusion s to what exactly caused the increased delta p measurement.No adverse consequences for the patient.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5398657
• MDR Text Key: 37105458
• Report Number: 8010762-2016-00050
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082117
• 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,Followup,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HQV 0605
• Device Catalogue Number: 70106.9352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention