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

Model Number N/A

Device Problems Moisture Damage (1405); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.At this time, the customer has not requested getinge to evaluate the iabp, as it is pending a repair quote.Additional information is being requested from the customer.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) emotted a constant alarm upon start-up.It was later reported that a fluid spill had occurred on the iabp.There was no patient involvement; thus no adverse event was reported.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) emitted a constant alarm upon start-up.It was later reported that a fluid spill had occurred on the iabp.There was no patient involvement; thus no adverse event was reported.

Manufacturer Narrative

The customer reported that saline fluid had spilled into the cs300 iabp unit, and it is considered a total loss.As a result, the iabp unit has been permanently removed from clinical service.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7857705
• MDR Text Key: 119661504
• Report Number: 2249723-2018-01550
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1