MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 30000-J

Device Problem Pressure Problem (3012)

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

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted if additional information becomes available.

Event Description

The ecc was started with the flow rate of 1.8l/m.The pressure is measured before (the inlet of the oxygenator) and after the oxygenator (arterial filter is from (b)(4))the pressure gradient is normally between 80 - 100mmhg or 150mmhg at maximum.However, this time, it experienced about 200mmhg gradient.Right after the ecc start-up, the pressure was about 240mmhg before and 160mmhg after the oxygenator.About 10min.Later, the pressure became 340-360 mmhg (before) and 160mmhg (after) and it continued until the end of ecc.After collecting the blood from the pump, the customer checked the oxygenator and it looked clean.Then, the customer cleaned the oxygenator with electrolyte solution and checked, but no redness or blood clot was observed.The customer re-primed the product, the pressure increase was confirmed again.No adverse effects on the patient were reported.(b)(4).

Manufacturer Narrative

The product was tested for its pressure drop behavior in the laboratory of the manufacturer.The pressure drop results were not in the accepted range as defined by mcp.At a flow rate of 1,5 l/min the pressure rose after approx.3 seconds, after approx.2 minutes a delta p of 155 mmhg was measured.At a flow of 2,8 l/min the pressure before the oxygenator (pven) was > 480 mmhg with a (part) of > 130 mmhg and a delta p of > 350 mmhg.Based on these results the reported failure "pressure rise" could be confirmed.A sap trend search was performed for p/n 70106.3733 failure code 1010 pressure rise and one similar complaint out of (b)(6) 2016 was found.The oxygenator lot is not the same as reported within the current complaint.Due to this information no systemic issue could be determined.The investigation of the manufacturer is still ongoing.

Event Description

(b)(4).

Manufacturer Narrative

The oxygenator was sawed off.It was checked if the quantity of gas mats is according to the specifications and if they are damaged or colored.No abnormalities were detected, 93 gas mats were counted which is according to the specifications of bop (b)(4).Dhr review results complaint (b)(4): affected product: basic lot 70104932 (serial number (b)(4)), packaging lot 70106414.The avz 7712 from (b)(4) (dms# (b)(4)) was reviewed on 2017-02-15.In process-step 17 ¿trocknen wasserseite¿, the temperature 47,4°c / 46,3°c was noticed as "temperature¿ but it should be 40°c +/- 5°c.That issue is already known.The root cause is a mistake in the avz.The correct temperature is not 40°c +/- 5°c but 50°c +/- 5°c, so the product is produced according the specification.This problem was handled in (b)(4).The nc is already closed.There were no references found, which are indicating a nonconformance of the product in question.Based on these results the most probable cause of the previously confirmed malfunction is unknown to mcp at this time.Mcp will decide about further investigation steps may be necessary.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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 ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6000923
• MDR Text Key: 57057163
• Report Number: 8010762-2016-00610
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: HMO 30000-J
• Device Catalogue Number: 70106.3733
• Device Lot Number: 70106414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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