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

Model Number N/A

Device Problem Inability to Auto-Fill (1044)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate.And found the tubing kinked at tubing assembly filter.The stm rerouted tubing and filter to prevent kinking.A functional tested was performed without any further issues.Subsequently, the stm replaced safety disk at was expired.The unit service was completed with safety, calibration, and functionality checks.Unit passed to factory specifications.Iabp was released to customer and cleared for clinical use.(b)(6).

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an autofill failure.It is unknown if there was any patient harm/injury; however there was no adverse event reported.

Manufacturer Narrative

Updated fields: a3, b4, g4, g7, h2, h6(evaluation method codes), h10, h11.Corrected fields: d5, h6(evaluation conclusion codes).

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an autofill failure.It is unknown if there was any patient harm/injury; however there was no adverse event 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: 10795735
• MDR Text Key: 215557761
• Report Number: 2249723-2020-01829
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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: 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
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1