MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Respiratory Distress (2045)

Event Date 11/23/2017

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death when a getinge iabp/ iab was involved.There was no alleged malfunction of the iabp, and no further information has been provided.If additional information is provided, a supplemental report will be submitted.

Event Description

It was initially reported that while supporting patient on a cs300 intra-aortic balloon pump (iabp) with a sensation plus 40cc balloon, a leak occurred in the balloon, and blood flecks were seen in the tubing.The iabp was put on standby and the physician removed the balloon.Therapy was then continued with a replacement balloon and the patient was eventually placed on continuous renal replacement therapy.Subsequently, updated information was received from the customer that the patient expired, and that the patient's death is not attributed to the iabp or the iab.It was also reported that the patient had inferior st-elevation myocardial infarction (stemi) occlusion of the posterior left ventricular branch of coronary artery; chronic total occlusion of the left anterior descending artery being fed from collaterals from the right coronary artery; cardiogenic shock and respiratory distress.Please note that a separate report will be submitted for the intra-aortic balloon complaint.

Manufacturer Narrative

Production device history record (dhr) review is not required as there was no alleged failure or malfunction of the intra-aortic balloon pump.(b)(4).

Event Description

It was initially reported that while supporting patient on a cs300 intra-aortic balloon pump (iabp) with a sensation plus 40 cc balloon, a leak occurred in the balloon, and blood flecks were seen in the tubing.The iabp was put on standby and the physician removed the balloon.Therapy was then continued with a replacement balloon and the patient was eventually placed on continuous renal replacement therapy.Subsequently, updated information was received from the customer that the patient expired, and that the patient's death is not attributed to the iabp or the iab.It was also reported that the patient had inferior st-elevation myocardial infarction (stemi) occlusion of the posterior left ventricular branch of coronary artery; chronic total occlusion of the left anterior descending artery being fed from collaterals from the right coronary artery; cardiogenic shock and respiratory distress.Please refer to related intra-aortic balloon report #2248146-2017-00721.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7156093
• MDR Text Key: 96109960
• Report Number: 2249723-2017-01089
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 06/27/2018
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 79