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

Model Number N/A

Device Problems Display or Visual Feedback Problem (1184); Power Problem (3010)

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 company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge stm that evaluated and discovered the subsequent issues deemed the unit as an "end of life" product and had discussions with the customer and it was confirmed that the unit was to be repaired and set back to factory standards before it could be cleared for clinical use.The stm then replaced the following parts: power supply and installed the 5000 hour kit on the motor, the condensation removal module, safety disk and batteries.However, the "low vacuum and auto-fill failure remained.The stm then replaced the blood detect tubing, purge manifold and drive manifold assembly, but the "low vacuum" alarm was still occurring.The decision was then made to take the unit to the stm's residence while the facility's administration decided whether to repair or scrap the unit, in the interim period, the stm then removed the old motor and checked all tubing for cracks and ordered a new motor and tubing to have on hand if repair was to move ahead.Subsequently the stm received approval from the facility approving the repair; new motor was installed along with all new vacuum tubing to create an established seal.The stm then ran all testing and put the unit to run overnight with a balloon attached; the unit passed all functional and safety tests per factory specifications and was thereafter returned to the customer and cleared for clinical use.

Event Description

The customer reported that the cs300 intra-aortic balloon pump (iabp) had a power supply issue.It was later reported by the getinge service territory manager (stm) that visited the site that the iabp presented with power supply failure, low vacuum alarm, auto-fill failure, expired safety disks, expired batteries and broken blood detect tubing with blood in the tubing.The circumstance of the event is unknown and it is also unknown if there was patient involvement when the reported power supply failure occurred, however, no 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8511414
• MDR Text Key: 142519432
• Report Number: 2249723-2019-00594
• Device Sequence Number: 1
• Product Code: DSP
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• 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?: Yes
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2008
• 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