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

Model Number N/A

Device Problem Gas Output Problem (1266)

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969); Cardiogenic Shock (2262); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2021

Event Type  Death  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during patient therapy, the cardiosave intra-aortic balloon pump (iabp) alarmed "gas loss in iab circuit," the screen went black and the unit suddenly shutdown.Additionally and unrelated, it was reported that the iabp unit alarmed ¿gas gain in iab circuit.¿ no patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during patient therapy, the cardiosave intra-aortic balloon pump (iabp) alarmed "gas loss in iab circuit," the screen went black and the unit suddenly shutdown.Additionally and unrelated, it was reported that the iabp unit alarmed ¿gas gain in iab circuit.¿ this patient with low output / inotropic/vasopressors was after pci in cardiogenic shock, and in the icu stabilized with iabp in a few hours, inotropic/vasopressors were greatly decreased, there was no weaning iabp initiated, so the patient was very swift stabilized.The sudden failure of the iabp was well tolerated, luckily.After stopping iabp, then 10 hours later the patient suddenly went into pea cardiac arrest, resuscitation failed, patient died.

Manufacturer Narrative

Updated fields: h6 (health effect - clinical code, investigation findings, health effect - impact codes, investigation conclusions).Corrected fields: h6 (component codes).A getinge field service engineer (fse) was dispatched to investigate.The fse performed endurance test and several leak tests, but was unable to reproduce the reported issue.No problem was found.The fse later conversed with the customer's biomedical engineer and the customer has decided to not repair the unit due to associated costs.The unit is no longer deployed and has been decommissioned.

Manufacturer Narrative

Analysis of production: (3331) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period (apr-2019 through mar-2021) was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Updated sections: b4, b7, g3, g6, h2, h10, h11.Corrected sections: h1, h6 (clinical code).

• Brand Name: CARDIOSAVE HYBRID INT TYPE E/F 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: 11645278
• MDR Text Key: 244899796
• Report Number: 2249723-2021-00736
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 50CC.(B)(6).
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Female