MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Abdominal Pain (1685)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.There is no information available as to whether parts were replaced/evaluated.A supplemental report will be submitted if further information is provided.(b)(6).Patient height:150cm.Not returned to manufacturer.

Event Description

It was reported that the while in use on a patient, the cardiosave intra-aortic balloon pump (iabp) had blood in the helium tubing observed 5 minutes earlier.Additionally, the customers stated that the patient is complaining of new onset abdominal pain.A physician was called to remove the iab and was advised that he could disconnect the balloon from the iabp and power it down.Blood has not reached the pump.Upon followup in the am, the charge nurse reports that the balloon was removed, and another has not been placed.At this time it is unknown if there was another iab placed.A separate report that will send to the report involve iab.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.Corrected fields: d1, d4.Additional information has been requested regarding the evaluation and status of the device, and if provided a supplemental report will be submitted.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11330318
• MDR Text Key: 232061369
• Report Number: 2249723-2021-00286
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• 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
• Treatment: SENSATION 34CC
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female