MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050-CA

Device Problems Circuit Failure (1089); Disconnection (1171); False Reading From Device Non-Compliance (1228); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet (b)(4) requested the product back for investigation but it has not been received.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

Description from the customer report: "after 3 days of treatment, perfusion noticed that the venous pressure was reading +5mmhg.They used external pressure transducer to compare the internal and arterial readings and found a 20 mmhg discrepancy.They have no way of confirming the venous pressure since there are no luers on the venous side of the hls circuit but assume that since the venous pressure is reading positive values, it mist also be erroneous.They are monitoring the system closely.The circuit was discontinued as they weaned the patient." (b)(4).

Manufacturer Narrative

An hls advanced 7.0 module was returned to the factory in (b)(4) for investigation.During flushing of the oxygenator, no clots were visible.After cleaning, a crack on the luer lock of the blood outlet connector was found.The responsible quality engineer was informed, and the crack was glued to seal it, and the module was sent to the qa-laboratory for performance testing.The results of the performance testing from the qa-laboratory showed that while the gas exchange performance tests were passed by the product, it failed the pressure drop performance test.The product was returned to the decontamination / complaints laboratory where all four sides of the oxygenator were sawn open and the mats were inspected for damage, marks, or other anomalies.On the gas side, small clots could be seen between the mats.On the water side, larger/more clots could be seen between the gas and the water mats.No clots were visible on the blood distribution plate on the blood outlet side.The count of the gas mats (74) was within specification (a count 72, 74, or 76 is specified).The investigation concluded the most probable root cause for the increased pressure drop was blockage of the oxygenator as a result of clotting.As clotting can result from a number of causes, including patient condition, the anticoagulation measures in use, and other clinical factors, the exact reason for the clotting cannot be identified.A systemic issue is not indicated.No further investigation or action is currently warranted.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• 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: 5723203
• MDR Text Key: 48420899
• Report Number: 8010762-2016-00383
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K101153
• 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
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: BEQ-HLS 7050-CA
• Device Catalogue Number: 70106.4847
• Device Lot Number: 70108810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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