MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 09/30/2021

Event Type  Death  

Manufacturer Narrative

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 that during intra-aortic balloon (iab) therapy, a leak occurred and blood was seen in the tubing.The patient was transferred to another cardiosave iabp to continue therapy.It was also reported that the patient later expired.This report is for the iab used.Two separate reports will be submitted for the two cardiosave intra-aortic balloon pumps used.

Event Description

It was reported that after approximately eight hours of intra-aortic balloon (iab) therapy, the console generated consistent gas loss alarms.Approximately three hours later, a balloon rupture occurred and blood was seen in the tubing.The console generated a catheter restriction alarm and was turned off.The patient was transferred to another cardiosave iabp to continue therapy.The first cardiosave iabp alarmed, and the patient was transferred to a second iabp.The second iabp produced the same alarms.The same iab was in use when the iabps were swapped.It was also reported that the patient later expired approximately 12 hours after therapy had been initiated.Patient death was not attributed to the devices.Other circumstances caused the death.

Manufacturer Narrative

Additional information - updated describe event or problem, other relevant history the device will not be returned to the manufacturer so we are unable to complete an evaluation.If additional information is provided, we will send a supplemental report.Complaint record id # (b)(4).

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 oct-2019 through sep-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

Manufacturer Narrative

Occupation: clinical engineer.Additional reporter name: (b)(6) icu nurse manager.Additional email address: (b)(6).Additional information - updated describe event or problem,date of death,patient information, brand name, catalog #, lot#, exp.Date,manufacture date, unique identifier (udi) # , pma/510(k)#, medical device ¿ problem code, device available for eval changed from yes to no.The device will not be returned to the manufacturer so we are unable to complete an evaluation.If additional information is provided, we will send a supplemental report.Complaint record id (b)(4).

Event Description

It was reported that after approximately eight hours of intra-aortic balloon (iab) therapy, the console generated consistent gas loss alarms.Approximately three hours later, a balloon rupture occurred and blood was seen in the tubing.The console generated a catheter restriction alarm and was turned off.The patient was transferred to another cardiosave iabp to continue therapy.It was also reported that the patient later expired approximately 12 hours after therapy had been initiated.This report is for the iab used.Two separate reports were submitted for the two cardiosave intra-aortic balloon pumps used under mfg report number 2249723-2021-02428 & mfg report number 2249723-2021-02426.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 12664439
• MDR Text Key: 277359170
• Report Number: 2248146-2021-00686
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• 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,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000138153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 10/21/2021; 12/02/2021; 12/22/2021
• Supplement Dates FDA Received: 11/09/2021; 12/03/2021; 01/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE / CH303787E9 CARDIOSAVE / CH212812F5; CARDIOSAVE / CH303787E9 CARDIOSAVE / CH212812F5
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 54 KG