MAUDE Adverse Event Report: HLS SET; HEART-LUNG BYPASS TUBING SET

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem Death (1802)

Event Type  Death  

Event Description

(b)(4).

Manufacturer Narrative

Info-lot number/catalog # for the disposable used in the treatment has been requested, but no info has been provided.The actual device was disposed of by the facility.A supplemental medwatch will be submitted if add'l info becomes available.(b)(4).

• Brand Name: HLS SET
• Type of Device: HEART-LUNG BYPASS TUBING SET
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4580068
• MDR Text Key: 17997127
• Report Number: 8010762-2015-00115
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 03/04/2015
• 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