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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemic Heart Disease (2493)

Event Date 04/04/2021

Event Type  Death  

Manufacturer Narrative

Occupation - icu manager.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported, during the early hours of (b)(6) 2021 the pump started alarming and the customer found that the port fill tubing on the safety disk had broken off.The customer started manual inflation until another pump was brought to the icu, hooked up the patient to the new pump and continued with therapy.The patient expired later in the day on (b)(6) 2021.The customer sent the getinge representative a picture of the safety disk and pump asking if it was a common occurrence for the fill port to break off as it did.Upon seeing the picture, the pump had been hit right on the safety disk or manipulated in some way as the safety disk was clocked counter clock wise.The getinge representative also talked and showed the pictures to service unit and they agreed and confirmed that is was hit/manipulated.There was no reported malfunction on the intra-aortic balloon(iab).A separate report will be submitted for the cs300 intra-aortic balloon pump(iabp).

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period on (b)(6) was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint#: (b)(4).H3 other text: device not returned.

Event Description

N/a.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 11746632
• MDR Text Key: 247995986
• Report Number: 2248146-2021-00270
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2021
• Patient Sequence Number: 1
• Treatment: CS300.; CS300
• Patient Outcome(s): Death
• Patient Age: 29 YR