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

Model Number BE-PLS 2050

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

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

Event Date 01/01/2015

Event Type  Injury  

Event Description

According to the customer: "on (b)(6) 2015 customer had the problem of inadequate oxygenation.Vv ecmo (veno-venous extra corporal membrane oxygenation) be-pls set has been placed on (b)(6) 2014.The state of the pt has been improved on (b)(6) 2014 so customer planned the separation from extracorporal membrane oxygenation, but in the morning on (b)(6) 2015 pt was not good and customer has decided to continue with ecmo procedure.Again they increased the fio2 to 100%, and postoxgenation result was 24.8 kpa, and repeated postoxgenation result was 24.8 kpa.So customer has to replace the be-pls 2050.After replacement: in the new oxygenator was measured po2 of 75.6 kpa." the prod was changed out.No consequences for the pt have been reported.(b)(4).

Manufacturer Narrative

The prod has not been requested back for investigation in the lab of the mfr as the failure is known to us.The malfunction has been thoroughly investigated within 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 spec.This data will be handled through a designated maquet trending process.Add'l info: the prod mentioned, is a tubing set and the included affected component has the contributing design function of the quadrox-id.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: DTZ, DWE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 222932112
• MDR Report Key: 4619408
• MDR Text Key: 5653905
• Report Number: 8010762-2015-00250
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 70102-7818
• Device Lot Number: 70099744
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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