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

Model Number 0998-00-0800-53

Device Problems Obstruction of Flow (2423); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/30/2021

Event Type  Death  

Manufacturer Narrative

Testing of actual/suspected device : a getinge field service engineer (fse) evaluated the iabp and checked for any blood or saline residue.The pim was checked and there was no sign of blood entering inside.The fse took a look at the back tubing in the fill manifold, between drive manifold and pressure/vacuum reservoir, and there was no sign of blood or saline.Gain calibrations and helium regulator calibrations were verified, which all were in spec.The fse continued to check the iabp device per manufacture specs, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) experienced a balloon catheter rupture.Blood was seen going down the catheter tube and possibly into the iabp.The patient was transferred to another cardiosave iabp to continue therapy.It was also reported that the patient expired.This report is for the replacement iabp.The initial iabp was reported in mfg report number 2249723-2021-02426 and the catheter was reported in mfg report number 2248146-2021-00686.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6, h10.It was later reported by the customer that the iabp had alarmed "gas loss" , which continued to alarm.Then the final alarm type was "obstruction/restriction.At this point the iabp was turned off and the patient was brought to the cath lab.A supplemental report will be submitted upon completion of our investigation.

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.This report is for the replacement iabp.The initial iabp was reported in mfg report number: 2249723-2021-02426 and the catheter was reported in mfg report number: 2248146-2021-00686.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYP 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12681026
• MDR Text Key: 277880673
• Report Number: 2249723-2021-02428
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• 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: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER.; BALLOON CATHETER
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 53 KG