MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET

Device Problems Increase in Pressure (1491); Filtration Problem (2941)

Patient Problem Death (1802)

Event Date 07/12/2015

Event Type  Death  

Event Description

It was reported the customer had a clotting problem and pressure issues with the device.The device failed and was replaced.The patient was eventually stabilized and removed from ecls machine, but did pass away.Ecls - extracorpeal lung support.(b)(4).Mfr ref#8010762-2015-00875.

Event Description

(b)(4).Mfr ref# 8010762-2015-00875.

Event Description

(b)(4).Reference mfr # 8010762-2015-00875.

• Brand Name: HLM TUBING SET
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 0000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4997088
• MDR Text Key: 22774865
• Report Number: 3008355164-2015-00156
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/11/2015,07/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 5 MO