MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Device Contamination with Body Fluid (2317)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817)

Event Date 11/07/2021

Event Type  Injury  

Manufacturer Narrative

Device not accessible for testing at this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) generated a check iab catheter alarm and the iab stopped inflating.The iab and insertion site were checked which showed minimal ooze and specs of blood in the tubing.Critical care outreach team (ccot) and specialist registrar (spr) were informed immediately.The patient then developed chest pains with electrocardiogram (ecg) changes in anterior leads.The surgical fellow was informed and reviewed the patient.Critical care outreach team (ccot) reviewed as well and requested for physiologist to come and look at the iab pump to see if they could troubleshooting.As they were discussing, back flow of blood developed in the catheter tubing at the catheter site.Surgical fellow then removed the iab.Patient remained stable throughout removal.Femoral stop applied as per protocol.This report is for the iabp.The associated intra-aortic balloon (iab) has been reported under medwatch report # 2248146-2021-00821.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the cs300 intra-aortic balloon pump (iabp) generated a check iab catheter alarm and the iab stopped inflating.The iab and insertion site were checked which showed minimal ooze and specs of blood in the tubing.Critical care outreach team (ccot) and specialist registrar (spr) were informed immediately.The patient then developed chest pains with electrocardiogram (ecg) changes in anterior leads.The surgical fellow was informed and reviewed the patient.Critical care outreach team (ccot) reviewed as well and requested for physiologist to come and look at the iab pump to see if they could troubleshoot.As they were discussing, back flow of blood developed in the catheter tubing at the catheter site.Surgical fellow then removed the iab.Patient remained stable throughout removal.Femoral stop applied as per protocol.This report is for the iabp.The associated intra-aortic balloon (iab) has been reported under medwatch report # 2248146-2021-00821.

Manufacturer Narrative

Updated fields: b4, b5, d1, d4 (version or model#, catalog#, serial#, udi#), g4, g7, h2, h10.Communication/interviews (4111) a getinge field service engineer (fse) indicated that the unit used during this event had several ¿check iabp catheter¿ alarms over the last hour of use, but no faults or errors.Additionally, the fse indicated that the injury caused to the patient was not attributed to the iabp.The system is fully operational with no blood contamination and has been put back into use.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Testing of actual/suspected device (10) a getinge field service engineer (fse) evaluated the unit used during this event had several ¿check iabp catheter¿ alarms over the last hour of use, but no faults or errors.Additionally, the fse indicated that the injury caused to the patient was not attributed to the iabp.The system is fully operational with no blood contamination and has been put back into use.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

• Brand Name: CS300 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: 12977249
• MDR Text Key: 282807931
• Report Number: 2249723-2021-02826
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 8FR. 50CC IAB.
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 68 KG