MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Inability to Auto-Fill (1044)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/03/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that, the cs100 intra-aortic balloon pump (iabp) did not work while trying to connect to the patient.The patient died until another device was brought and exchanged.

Event Description

Initially it was reported that the patient died when the cs100 intra-aortic balloon pump (iabp) did not work and that the iabp was exchanged for a new device.Later, clarification was received that the patient was in cardiac arrest so iabp therapy was requested.The initial iabp used did not work, it failed autofill while trying to start therapy.The iabp was then exchanged for another iabp and therapy was able to be provided and cabg was arrested.Additionally it was reported that it was unknown if the patient was resuscitated, or the current status of the patient, but the patient did not die from the device.

Event Description

N/a.

Manufacturer Narrative

Updated fields: h2.Corrected fields: e3, h1, h6 (health effect - impact codes), h10, h11.Contact name mentioned in e1 in mfg follow-up #2 was not complete.Full contact name is: (b)(6).

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and was not able to reproduce the reported issue.In the examination made on the device, it was seen that it gave autofill failure - no helium error many times on device, helium tube mechanical manometer, helium tube pressure transducer, helium tube gasket checked and helium tube-regulator inter- leakage checked.No malfunction was detected in the device.The device was tested by connecting the test catheter and the system trainer.The device was operated by simulating ecg and pressure values.Auto mode feature was tested, it was seen that the device automatically switches to the other trigger when the selected trigger data is interrupted.The device's safety disk leak test, k6, k6a, k7, k8 leak test, pneumatic performance test and engine calibration test were performed.Moreover autofill calibration test and helium tank calibration were done.The date/time parameters of the device were checked.Device clock fixed.The device was delivered in working condition.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 15782955
• MDR Text Key: 303533885
• Report Number: 2249723-2022-02932
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K031636
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Death