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 Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was disposed by the hospital; therefore no manufacturer laboratory investigation was possible.Clotting is a known phenomenon and has been investigated in a previous complaint.The cause of this failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.Based on this a confirmation of the failure is not possible.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

According to the customer: "intensive trombosis was observed both in inlet and outlet of oxygenator.Follow up was maintained inorder to have act value between 150-180 sec.Lowest act value was observed 136 sec., highest value was 254 sec.After observation of thrombus in morningtime, heparin dosage was increased and 500iu was flashed, 2 unit ffp is given.After 14.00 lt it was observed that thrombus was no more proceeding.Blood gas analysis was performed from outlet of oxygenator.As a result of gas analysis it was observed that oxygenation was good and decided to run ecmo with same set for a while" (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: 6132059
• MDR Text Key: 61407313
• Report Number: 8010762-2016-00695
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 701027818
• Device Lot Number: 70113506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• Date Device Manufactured: 07/01/2016
• 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