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

Model Number N/A

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 11/29/2017

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.Additional information has been requested.A supplemental report will be sent upon receipt.

Event Description

A customer reported that while in use on a patient, the cs300 intra-aortic balloon pump (iabp) stopped working, and multiple errors occurred.It was reported that the patient expired while obtaining a replacement iabp.It was not reported that the patient death was attributed to the iabp event.

Manufacturer Narrative

A getinge field service engineer (fse) confirmed with the staff that the iabp alarmed "leak in iab circuit" and stopped inflating balloon during use.The fse then verified the alarm in the iabp logs, and was able to duplicate alarm during testing.The fse found that the iab fill connector on the side of the safety disk was partially tightened.He then tightened the connector and performed functional testing, as well as, safety check to factory specifications.The iabp passed all functional and safety checks was released for clinical use.There were no parts replaced.

Event Description

A customer reported that while in use on a patient, the cs300 intra-aortic balloon pump (iabp) stopped working, and multiple errors occurred.It was reported that the patient expired while obtaining a replacement iabp.It was not reported that the patient death was attributed to the iabp event.

• 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: 7143967
• MDR Text Key: 95690342
• Report Number: 2249723-2017-01060
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2008
• 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