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

Model Number 0998-00-3023-53

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2021

Event Type  Death  

Manufacturer Narrative

A supplemental report will be submitted upon receipt of additional information. Not returned to the manufacturer.

Event Description

It was reported that a (b)(6) male had emergency cabg surgery on the evening of (b)(6) 2021, came to the icu on a cs300 intra-aortic balloon pump (iabp). During the early hours of (b)(6) 2021 the pump started alarming and they found that the port fill tubing on the safety disk had broken off of the iabp. The customer started manual inflation until another pump was brought to the icu, hooked up the patient to the new pump and continued with therapy. The patient expired later in the day on (b)(6) 2021. The customer sent a picture of the safety disk and iabp asking if it was a common occurrence for the fill port to break off as it did. Upon seeing the picture it was quite obvious the unit had been hit right on the safety disk or manipulated in some way as the safety disk was clocked counter clock wise. I also talked and showed the pictures to service and they agreed and confirmed that is was hit/manipulated. The customer are trying to determine if the iabp going down was a factor in the patient expiring. This report is for the first cs300 iabp. The second iabp is being reported separately and the intra-aortic balloon catheter used in this event has been reported separately under medwatch 2248146-2021-00270.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11754455
• MDR Text Key: 248244262
• Report Number: 2249723-2021-00917
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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,user f

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/30/2021 Patient Sequence Number: 1

Treatment

INTRA-AORTIC BALLOON CATHETER