MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-33

Device Problem Failure to Sense (1559)

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

Event Date 08/03/2021

Event Type  Death  

Manufacturer Narrative

Communication/interviews : a getinge field service engineer (fse) advised that the end user check the inner lumen for any obstruction or clot, and if they would be able to aspirate blood.The end user indicated everything seemed to be ok.The fse then advised the end user to replace the transducer.When the end user was replacing the transducer, it was observed that the end user had forgotten to open the 3-way stop cock at the patient end which had resulted in the reported issue.Once the 3-way stop cock was opened and the iabp unit was zeroed, it was observed to be working properly.The fse has indicated that the event was caused due to user error.Testing of actual/suspected device : the fse arrived at the customer's site at a later date and all functional and safety checks were performed and found to be working to factory specifications.The iabp was then cleared for clinical use and returned to the customer.A supplemental report will be submitted upon completion of our investigation.The full name of the event site was shortened due to field character limit; the full name is (b)(6) hospital.

Event Description

It was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) was not showing the correct pressures.No patient harm, serious injury or adverse event was reported.It was later reported on (b)(6) 2021 that the patient had expired on (b)(6) 2021.The customer has not attributed the patient's death to the device.

Manufacturer Narrative

This report is for the cardiosave iabp.A separate report for the linear 7.5 fr.40cc iab was submitted under mfg report number 2248146-2021-00555.Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period sep 2019 through aug 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• 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: 12380058
• MDR Text Key: 268559066
• Report Number: 2249723-2021-01936
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• UDI-Public: 10607567109008
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

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 Model Number: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LINEAR 7.5 FRENCH 40CC; LINEAR 7.5 FRENCH 40CC
• Patient Outcome(s): Death
• Patient Sex: Prefer Not To Disclose