MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET

Model Number 70105.2794

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Maquet cardiopulmonary (b)(4) is not able to perform an investigation since the device is not available.Clotting is a known phenomenon to maquet cardiopulmonary (b)(4).Anticoagulation has many diverse factors which are influenced by medication and each patient's individual system.Based on the information available at this time, a failure confirmation is not possible.If further information becomes available, a supplemental medwatch will be submitted.Additional information: the product mentioned 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.(b)(4).

Event Description

(b)(4).

Event Description

(b)(4).

Event Description

(b)(4).Reference uf/importer # 3008355164-2015-00156.

• Brand Name: HLM TUBING SET
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; 2229321132
• MDR Report Key: 4997078
• MDR Text Key: 22778342
• Report Number: 8010762-2015-00875
• Device Sequence Number: 1
• Product Code: DTZ
• 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,health
• Type of Report: Followup,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 70105.2794
• Device Catalogue Number: BEQ-HLS 7050 USA
• Event Location: Hospital
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 6 MO
• Patient Weight: 6