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

Model Number N/A

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem Death (1802)

Event Date 03/04/2019

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 customer has not requested getinge service in connection with this event.Additional information has been requested and we will submit a supplemental report if necessary.

Event Description

The customer reported that prior to use on a patient, they broke the fill port on the cs300 intra-aortic balloon pump (iabp) and requested a rental unit.It was then reported that a getinge therapy specialist later spoke with the customer and was advised that the intra-aortic balloon catheter (iabc) was inserted in the icu and the fill port was found to be broken off when troubleshooting was done for an autofill failure.A getinge emergency support lead coordinator followed up with the customer to clarify details of the event and learned that the iabp unit in question did not ever support the patient, but that the patient expired after being supported on a second console which was switched out by the perfusionist when he arrived on the scene.In addition, the customer did not call for assistance until after the patient was receiving support on the second console.At this time, it is unknown if what transpired with this unit had any impact on the patient.The patient's death and further details thereof will be reported under a separate report citing the details of the second iabp console which was in use at the time of the patient's death.

• 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: 8466191
• MDR Text Key: 141085145
• Report Number: 2249723-2019-00500
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2001
• 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: 63
• Patient Weight: 66