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

Model Number BE-PLS 2050

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Myocarditis (2470)

Event Date 12/25/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, a pt with chest pain arrived another facility.At this facility, the pt complained of nausea and vomiting pain, so a ct was performed.Pericardial effusion was diagnosed, so pericardiocentesis was implemented.After pericardiocentesis, the pt's condition was stable but suddenly the pt complained of lower back pain.On (b)(6) 2014, with sudden lower back pain, the pt was transported to (b)(6).After a visit to the emergency room, the pt's condition worsened.Cpr and ecmo therapy were initiated.Blood was observed leaking from the gas outlet port, at a rate of 15-20cc per hr.The device was exchanged when the pt's condition was stable.There was no delay in treatment.The pt expired due to myocarditis.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary has not received the device for eval.A statement from the clinic was received on (b)(6) 2015 stating that the death of the pt was not caused by a malfunction of the device.Add'l info: the product mentioned under section d 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.A supplemental medwatch will be submitted when add'l info becomes available.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse, 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4454350
• MDR Text Key: 21775114
• Report Number: 8010762-2015-00014
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 701002.7818
• Device Lot Number: 70099577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 50 YR
• Patient Weight: 70