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 Problems Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

Patient Problems Bradycardia (1751); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  Death  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) the unit had a fiber optic sensor failure.When the balloon was trying to fill it would make an audible alarm with ¿fiberoptic sensor fail¿.It showed the pump on the screen where it was filling but it was short quick burst, under x-ray filling could not be seen.There was never any pressure or augmentation levels.The unit was changed to ecg trigger vs pressure and still never got filling.There was no visible damage to the fiber optic.The hospital used 1 console with 1 iapb, then changed to another console with a separate iapb, then used a 3rd console with the 2nd iapb.Therapy was never initiated with any console or any iab or was support.Cpr was being performed, patient had no pressure, patient was intubated, and patient had v-fib arrest post pci.The patient had expired.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11 corrected fields: b5, h6(clinical code & problem code).A getinge field service engineer (fse) was not dispatched to evaluate the iabp unit, customer have a trained biomed who takes care of these issues.Additional information on this complaint was requested but the customer could not provide any other information, therefore this complaint is being closed.If information is received, we will reopen and update the complaint accordingly.H3 other text : evaluation not requested by complaintant.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a fiber optic sensor failure.When the balloon was trying to fill it would make an audible alarm with ¿fiberoptic sensor fail¿.It showed the pump on the screen where it was filling but it was short quick burst, under x-ray filling could not be seen.There was never any pressure or augmentation levels.The unit was changed to ecg trigger vs pressure and still never got filling.There was no visible damage to the fiber optic.The hospital used 1 console with 1 iapb, then changed to another console with a separate iapb, then used a 3rd console with the 2nd iapb.Therapy was never initiated with any console or any iab or was support.Cpr was being performed, patient had no pressure, patient was intubated, and patient had v-fib arrest post pci.The patient had expired.Related cardiosave mfg report number 2249723-2022-01646 and related iab mfg report numbers 2248146-2022-00538 and 2248146-2022-00539.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14987723
• MDR Text Key: 295704468
• Report Number: 2249723-2022-01642
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB CATHETER BALLOON UNIT X2
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 90 KG