MAUDE Adverse Event Report: GAMBRO ROSTOCK MARS; MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

Model Number MARS KIT GAMBRO, TYPE 1115/1-PRISMARS

Device Problem Fluid/Blood Leak (1250)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 09/07/2015

Event Type  Injury  

Manufacturer Narrative

The involved kits sets have been requested to be returned.

Event Description

A critically ill patient in (b)(6) was undergoing treatment with a molecular adsorbent recirculating system (mars) on a prisma machine and prismars kit.The patient had advanced liver failure, unconscious, intubated with respiratory support and a norepinephrine drip.During treatment, the patient had an estimated blood loss of 400 ml following an external blood leak from the prismars kit.The patient was transfused with a unit of blood following this event.It was reported the patient expired sometime later.

• Brand Name: MARS
• Type of Device: MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
• Manufacturer (Section D): GAMBRO ROSTOCK; friedrich-barnewitz-str. 3; rostock 18119 ; GM 18119
• Manufacturer Contact: helke mohrholz ; friedrich-barnewitz-str. 3; rostock ; GM ; 3812526612
• MDR Report Key: 5136193
• MDR Text Key: 27767690
• Report Number: 3007697864-2015-00001
• Device Sequence Number: 1
• Product Code: NKL
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K033262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2017
• Device Model Number: MARS KIT GAMBRO, TYPE 1115/1-PRISMARS
• Device Catalogue Number: 800475
• Device Lot Number: 0000021041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 110