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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and it failed the k7/k8 and safety disk leak tests.To resolve the issue, the fse replaced the drive manifold and in addition, the safety disk assembly was replaced due to expiration by hours.The iabp was able to pass all the leak tests, and the fse performed all functional and safety checks to meet factory specifications.The unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported during use on a patient, that the cs300 intra-aortic balloon pump (iabp) had an iab leak in circuit.The unit was swapped out for another without incident.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported during use on a patient, that the cs300 intra-aortic balloon pump (iabp) had an iab leak in circuit.The unit was swapped out for another without incident.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, e1 (event site email), g4, g7, h2, h10.

Event Description

It was reported during use on a patient, that the cs300 intra-aortic balloon pump (iabp) had an iab leak in circuit.The unit was swapped out for another without incident.No patient harm, serious injury or adverse event was reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11066997
• MDR Text Key: 225340463
• Report Number: 2249723-2020-02216
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 44