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

Catalog Number 0998-00-3023-XX

Device Problems Decrease in Suction (1146); Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Nausea (1970); Pain (1994)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed as the serial number of the iabp was not provided by the facility.At this time, the facility has not determined which iabp was in use during this event.Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that a cs300 iabp (intra-aortic balloon pump) with a maquet 7.5fr 40cc iab was placed on a patient on (b)(6) 2017.On (b)(6) 2018 the iabp alarmed "low vacuum" and the patient was repositioned.The iabp then alarmed "check tubing" and blood was noted in tubing.The patient had abdominal pain and the iabp was placed on standby.The patient had urge to have bowel movement, was nauseated and diaphoretic.The iabp was then removed.Vascular surgery consult was done.A computed tomography (ct) of chest, abdomen and pelvis was negative for direction or aneurysm.The patient was planned for high risk percutaneous coronary intervention on 1/2 impella percutaneous lvad (left ventricular assist device) placement and ptca (percutaneous transluminal coronary angioplasty) and des (drug-eluting stent) and l (left)lm/lcx (left main/left circumflex artery) isr (in-stent restenosis) patient death occurred on (b)(6) 2018.The facility does not attribute the death to the device.A separate report was submitted for the related intra-aortic balloon under mfg report number: 2248146-2018-00046.

• 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: 7311840
• MDR Text Key: 101769858
• Report Number: 2249723-2018-00338
• 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
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3023-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/07/2018
• 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: 79 YR
• Patient Weight: 85