MAUDE Adverse Event Report: DATASCOPE FAIRFIELD; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problems Material Rupture (1546); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Non specific EKG/ECG Changes (1817)

Event Date 10/29/2015

Event Type  Death  

Manufacturer Narrative

The device has not yet been returned to maquet for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

On (b)(6) 2015, a company representative reported the following: "customer requested preventive maintenance.Upon arrival found signs of blood in purge tubing.Bio-med had not noticed blood in tubing.Inquired on blood back and was told director of risk management reported a balloon rupture to cardiac assist account manager (caam).Caam is currently out on family leave and may not have received voicemail.Director sent notification of event to fda as well as maquet via us mail.Requested copy of form.Will forward when received.Patient balloon ruptured and was removed around 8pm (b)(6) 2015.Patient was treated medically.Another balloon was not inserted.Patient expired morning of (b)(6) 2015.Exact time asku.Director did not have patient information available during conversation.Information on form.Verified 'blood detected' alarm in fault logs entered at time of incident." this event occurred while the iabp was being used on a patient.The customer reported the following via a non-numbered medwatch dated (b)(6)2015: "patient was on intra-aortic balloon pump.At 2051, pump alarm sounded stating blood detected.Helium line full of blood and balloon not inflating.Interventional cardiologist was notified.Heparin was stopped for 3 hours, then iabp was discontinued.A ruptured balloon was noted.Patient had a history of coronary artery disease with 3-vessel cabg.She had chest pain with ekg changes and was taken to the cath lab.No sites for ischemia were amenable to any intervention.Iabp was inserted and she was transferred to the icu with improvement over 12 hours.Then urine output of patient again began to drop in the afternoon of (b)(6).In the evening, there was loss of integrity of the balloon.It was decided to medically image after discontinuation of the balloon.She coded at 0400 and could not be resuscitated." the blood back event occurred on (b)(6) 2015, and the patient died on (b)(6) 2015.(b)(4).

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 5247854
• MDR Text Key: 32090084
• Report Number: 2248146-2015-01041
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• 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
• Patient Age: 67 YR