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

Model Number BE-HLS 7050

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

Patient Problem Hypoxia (1918)

Event Date 02/04/2015

Event Type  Injury  

Event Description

It was reported the hls set had deteriorating gas exchange capability.After a few days, with slowly deteriorating post membrane po2, the decision was made to change the circuit.With further post membrane drop to 43mmhg, the decision was confirmed.The patient went on the eolia cardiohelp on (b)(6) 2015 for ards with a 31fr avalon cannula.The circuit was changed on (b)(6) 2015 due to downward trending of post membrane po2.The lowest was 45mmhg.The patient remained on the first circuit for 14 days.The patient was not hypercoagulable and had not been issued anticoagulation.Acts were 160-180 seconds.Flows have been >5.0 1pm his entire run.Fio2 is 100% with sweeps at 81pm and weaned down to off.Ref.: #(b)(4), customer ref.:(b)(4).Ards - adult respiratory distress syndrome.This event is related to medwatch report # 8010762-2015-00232 for the second circuit.

Manufacturer Narrative

The device is not available for investigation, as it was discarded by the facility.The failure is known to maquet cardiopulmonary and has been thoroughly investigated.Based on the results obtained during the investigation and the information available at this time, the product met process specifications with no abnormalities.The failure is being handled through a designated maquet cardiopulmonary tracking and trending process.Additional information: the product mentioned under is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: DTZ
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 222932112
• MDR Report Key: 4593751
• MDR Text Key: 18258960
• Report Number: 8010762-2015-00231
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 70104.7753
• Device Lot Number: 70099496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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