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

Model Number 0998-00-0800-53

Device Problems No Audible Alarm (1019); Inability to Auto-Fill (1044); Device Contamination with Body Fluid (2317); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Due to character restrictions in block e1 event site name : (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit had issues; during the night the pump was alarming with gas loss alarms, and that morning there was an auto fill failure.There were no signs of blood in the helium tubing at those times.Later, the patient called staff to the room as he saw blood in the helium tubing.The nurse on at the time reports that there was a copious amount of blood, but felt that it was disconnected from the pump before any blood reached it.The pump failed to alarm them to any leak in the catheter.Currently the patient is stable and received a replacement iab.There was no patient harm.It was suggested that they report the pump to their biomed department in case any blood did reach it.

Event Description

N/a.

Manufacturer Narrative

Additional information: poc - (b)(6).It was reported that cardiosave intra-aortic balloon pump (iabp) blood drew back into air line.(b)(6) is the educator in the ccu and relaying the information second hand.She reports that during the night the pump was alarming with gas loss alarms, and that morning there was an auto fill failure.There were no signs of blood in the helium tubing at those times.She states that at 1:19 today the patient called staff to the room as he saw blood in the helium tubing.The nurse on at the time reports that there was a copious amount of blood, but felt that she disconnected from the pump before any blood reached it.(b)(6) is reporting the incident because she says that the pump failed to alarm them to any leak in the catheter.She looked at the alarm history and the only alarm noted at the time of the leak was a "gas gain" message.She states that the alarm happened because the rn disconnected the catheter from the pump.Currently the patient is stable and received a replacement iab.A getinge field service engineer (fse) when i arrived i found blood in the pneumatic interface module (pim).Pim replacement is from customers stock.Replaced pim and performed full functional and safety tests.Returned to customer and cleared for clinical use.There was a patient involvement but no harm reported.

• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 17428955
• MDR Text Key: 320132750
• Report Number: 2249723-2023-03443
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ARROW BALLOON
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 89 KG