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

Model Number BEQ-HLS 7050 USA

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: ¿has any center ever told you about their oxygenator being completely covered in fibrin on the arterial side of the oxygenator¿ i responded that i did not recall that description and i asked if they had experienced it and if it was a qid or hls circuit.She sent a picture of an hls circuit.(b)(4).

Manufacturer Narrative

(b)(4).In relation to the customer's request for information regarding fibrin deposits, the therapy application manager confirmed that increased fibrin deposits on the oxygenator membrane is a known phenomenon and is a typical observation for patients with sepsis on ecmo.Based on the investigation and trending for this issue, a systemic issue is not indicated, and the increase in fibrin deposits is a known risk associated with patients with sepsis on ecmo, therefore no further investigation or action is currently warranted in addition to continued periodic monitoring, and the complaint will be closed.

Event Description

Ref.:tw id # (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: 6286540
• MDR Text Key: 66358451
• Report Number: 8010762-2017-00021
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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