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

Model Number 0998-00-0800-53

Device Problem Failure to Zero (1683)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2021

Event Type  Death  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to the customer's site.The fse o performed system checkout as required.The fse was unable to reproduce zero issue customer experienced.The iabp unit passed all functional and safety tests per factory specifications.Returned to customer and cleared for clinical use.Upon completion of our investigation, a supplemental report will be submitted.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon failed to zero on the cardiosave iab pump (iabp).The customer switched pumps as the balloon was inserted and it then performed as expected.Patient had a st-elevated myocardial infarction (stemi) procedure during day and passed at 1:25 am.The death was not attributed to iabp by the facility.Please refer to related mfg report number 2248146-2021-00398 on the involved intra-aortic balloon (iab).

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: b5, g1(contact person).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon failed to zero on the cardiosave iab pump (iabp).The customer switched pumps as the balloon was inserted and it then performed as expected.Patient had a st-elevated myocardial infarction (stemi) procedure during day and passed at 1:25 am.The death was not attributed to iabp by the facility.Please refer to related mfg report number 2248146-2021-00398 on the involved intra-aortic balloon (iab).Please refer to related mfg report number 2249723-2021-01318 for second iabp used in the event.

• Brand Name: CARDIOSAVE HYBRID TYPE G PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12028257
• MDR Text Key: 257109692
• Report Number: 2249723-2021-01304
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Weight: 75 KG