MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLS-SET OR PLS -SET; NONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peroneal Nerve Palsy (2362)

Event Type  Injury  

Event Description

It was reported that three pts developed paralysis during iabp (intra-aortic balloon pump) and ecmo (extra corporeal membrane oxygenation) combined.This is pt 2 of 3, refer to mfg report # 8010762-2014-01229 and 8010762-2014-01231 for the other two pts.(b)(4).

Manufacturer Narrative

The device is not available for eval.A supplemental medwatch will be submitted if additional info becomes available.

• Brand Name: HLS-SET OR PLS -SET
• Type of Device: NONE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4276152
• MDR Text Key: 5010582
• Report Number: 8010762-2014-01230
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2014

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
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability