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

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

Getinge field service engineer (fse) evaluated the iabp and attempted to reproduce the reported issue with a test balloon, but the error did not occur during normal operation of the iabp unit.However, the fse discovered that the error can be produced when the intra-aortic balloon (iab) is removed during the inflate/deflate cycle which is the normal operating procedure.The fse completed a preventative maintenance (pm) service, and then performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.(b)(6).

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) generated an iab disconnect alarm.The customer reported to have checked all connections and observed no sign of a balloon leak and all connections were secure.A getinge employee suggested to swap the iabp unit out and to send to bio-med for evaluation.There was no report of patient harm, serious injury or adverse event.Patient height: 172 cm.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10781514
• MDR Text Key: 218937697
• Report Number: 2249723-2020-01815
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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 Age: 67 YR
• Patient Weight: 69