MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number UNKNOWN

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/27/2022

Event Type  Injury  

Manufacturer Narrative

At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event. A supplemental report will be submitted if additional information is provided. Not returned to manufacturer.

Event Description

It was reported that during use on a patient, the intra-aortic balloon pump (iabp) experienced a blood back event. Blood had been observed in the inner lumen line running to the flush bag. The end user proceeded to flush the line until cleared. It was noted that this took a few minutes. Directly after, the patient developed some chest tightness and shortness of breath for a period of about 10 minutes. The iabp unit had not been placed in standby per the instructions for use during the flushing. The importance of performing flushing while the iabp unit was in standby was communicated to the customer and the possible clinical results if not followed correctly. The end user stated the patient seemed fine clinically at the time and therapy was being delivered as expected. The patient's chest x-ray was later provided which revealed that the catheter was not in the proper position. This was communicated to the end user who later sent a text message stating the patient was doing fine. At this time, the customer has not attributed this event to the device. The associated intra-aortic balloon (iab) associated with this event has been reported under medwatch 2248146-2022-00300.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON PUMP
• 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14214604
• MDR Text Key: 290118928
• Report Number: 2249723-2022-00942
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/26/2022 Patient Sequence Number: 1

Treatment

INTRA-AORTIC BALLOON.