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

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Date 01/28/2019

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformance's in the production dhr related to the reported event.A getinge field service engineer (fse) was dispatched to evaluate the iabp unit.The fse ran functional checks, testing passed and no issues were found.Additionally, the fse performed five passing fiber optic tests without any failures to report.The fse cycled the iabp unit overnight, 24 hours on balloon and simulator for repeatability test before returning to clinical use.

Event Description

It was reported that the intra-aortic balloon (iab) was not working properly; the fiber optics was not functioning.The staff tried to swap out the cs300 intra-aortic balloon pump (iabp) but was unsuccessful.It was later reported on (b)(6) 2019, that the patient expired one week after iab therapy was discontinued.There was no reported malfunction of the iabp.It was reported that when the iab failed, the unit emitted an appropriate alarm.This report is related to iab complaint# (b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was not working properly; the fiber optics was not functioning.The staff tried to swap out the cs300 intra-aortic balloon pump (iabp) but was unsuccessful.It was later reported on (b)(6) 2019, that the patient expired one week after iab therapy was discontinued.There was no reported malfunction of the iabp.It was reported that when the iab failed, the unit emitted an appropriate alarm.This report is related to iab complaint# (b)(4).

• 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: 8380341
• MDR Text Key: 137509311
• Report Number: 2249723-2019-00322
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2007
• 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 Weight: 80