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

Model Number BE-PLS 2050

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "there was clotting inside the oxygenator within 24 hours during the ecmo period.The value of aptt is 33.1s.The rpm is 4265." (b)(6).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product for investigation but the product was not available.Therefore no laboratory investigation could be performed by the manufacturer.Thus the reported failure could not be confirmed.The most probable root cause of the event is not adequate anticoagulant therapy with heparin.Clinical assessment: it is an off-label use of the pls system.We have a ptt between 60 and 90 sec in the corresponding ifu.The specified value in the complaint report of 33.1 sec appt is significantly lower than this recommendation.On point 5.2 safety instructions for the extracorporeal circulation in section 4: the partial thromboplastin time (ptt) should be in the range from 60 to 90 seconds.An antithrombin iii(at iii) value in the normal range is required for reliable anticoagulant therapy with heparin.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, 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: 6581811
• MDR Text Key: 75836316
• Report Number: 8010762-2017-00161
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080592
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 701027818
• Device Lot Number: 70115328
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Date Device Manufactured: 11/01/2016
• 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