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

Model Number N/A

Device Problems Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.A getinge service territory manager (stm) was dispatched to evaluate the iabp unit for the reported balloon rupture.The stm did not observe blood intrusion into the pump and no pump failure was identified.The iabp unit passed all calibration, functional, and safety tests per factory specifications.The unit was returned to the customer and cleared for clinical use.Several attempts have been made to obtain additional information from the customer regarding the patient adverse event.However, despite our best efforts, no response has been provided.If additional information is provided at a later date, a supplemental report will be submitted accordingly.

Event Description

It was reported that the intra-aortic balloon (iab) ruptured during patient therapy with the cardiosave intra-aortic balloon pump (iabp).The customer requested that the unit be checked out.There was no reported malfunction of the iabp.No patient information was made available and there was no indication of actual or potential for harm or death.This event was initially documented as a non-reportable event, as there was no reported malfunction of the involved iabp.It was later confirmed with the facility¿s biomedical engineer that this iabp unit may have been in use during or following the adverse event complaint reported under mfg report number 2248146-2019-00641.The customer reported that ¿the catheter was sent with the patient to the coroner¿s office¿.No further information or clarification was provided.There was no reported failure of the iabp and the facility has not attributed the patient death to the iabp unit.

• 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 9154223
• MDR Text Key: 161164577
• Report Number: 2249723-2019-01586
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 83