MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PLS 2050

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 12/07/2015

Event Type  Injury  

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 product was requested to return for manufacturers laboratory investigation.It was not received by the manufacturer yet.The investigation is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

According to the customer: "during pls application, blood clot was occurred in the oxygenator membrane and rf 32 after replacement, there was no problem." (b)(4).

Manufacturer Narrative

This complaint group investigated the reported issue of clotting in the oxygenator quadrox pls-i.The issue of clotting in the rotaflow rf 32 was investigated in the complaint (b)(4).Due to the lack of clinical information about the case (not available from the customer), the investigation could not establish a definitive root cause for the reported clotting.However, investigation of the product concluded that the pls set under investigation with the main components rf 32 and quadrox pls-i performed as specified.The clotting is considered to have been caused by clinical application issues (most likely inadequate de-airing), and the clotting was a result of prolonged blood-to-air contact.A device history record of the affected lot has been investigated and no abnormality was found.Investigation of this complaint and trending for this issue indicates that there is no systemic issue, and no further investigation or action is warranted other than regular periodic monitoring, and complaint will be closed.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 5332437
• MDR Text Key: 34592469
• Report Number: 8010762-2015-01283
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 70102.7818
• Device Lot Number: 70107592
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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
• Patient Outcome(s): Required Intervention