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

Model Number N/A

Device Problems Battery Problem (2885); Power Problem (3010)

Patient Problem Death (1802)

Event Date 01/09/2019

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 field service engineer (fse) was dispatched to investigate the iabp unit once it was returned to the original hospital.The fse evaluated the iabp unit and both functional test and battery performance (discharge) tests passed.The junior power supply functioned properly and battery switching was also functional.The battery in slot 1 was found to be a bit tight but was then adjusted and corrected during the visit.No parts were replaced.The full name of the event site is (b)(6) hospital.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was in use on a patient for cardiac support while being transported from one hospital to another for open heart surgery.The cardiosave console was taken out during patient transport with battery operation.The nurse noticed that battery 1 was finished and battery 2 was discharging (1/3 power), and decided to switch the junior power supply to slot 1 during transport.According to the nurse, the iabp power shut down during the switching of battery 1 and the junior power supply (ac converter).The user restarted the iabp and resumed therapy to the patient.The iabp unit operated normally afterwards in the ambulance until the patient arrived to the receiving hospital.It was reported that the patient died after a few days due to other complications.It was also later reported that the user experienced difficulty when removing the battery.The facility has not attributed the patient's death to the iabp.A separate report was submitted for the involved intra-aortic balloon catheter under mfg #2248146-2019-00077.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was in use on a patient for cardiac support in icu, before being transported from one hospital to another for open heart surgery.The cardiosave console was taken out for patient transport with battery operation.While in icu, the nurse noticed that battery 1 was finished and battery 2 was discharging (1/3 power), and decided to switch the junior power supply to slot 1 during transport.According to the nurse, the iabp power shut down during the switching of battery 1 and the junior power supply (ac converter).The user restarted the iabp and resumed therapy to the patient.The iabp unit operated normally afterwards in the ambulance until the patient arrived to the receiving hospital.It was reported that the patient died the next day due to other complications.It was later reported that the user experienced difficulty when removing battery 1.The facility has not attributed the patient's death to the iabp.A separate report was submitted for the involved intra-aortic balloon catheter under mfg #2248146-2019-00077.

• Brand Name: CARDIOSAVE HYBRID TYPE G PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8323603
• MDR Text Key: 135613583
• Report Number: 2249723-2019-00213
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 55