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

Model Number 0998-00-0800-45

Device Problems Restricted Flow rate (1248); Pumping Stopped (1503)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2023

Event Type  Death  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarm was "catheter restriction" displayed.Patient went to the ed, cath lab for stent and transvenous pacemaker, and admitted to cicu.He was maintained in the icu and transferred to telemetry (b)(6) 2023 1630pm.On (b)(6) 2023 2342, patient experiencing flash pulmonary edema, and chest pain relieved by nitro -- ekg concerning for new l bbb.The patient went back to the cath lab for iabp placement and brought back to the icu, with plans for possible pci (b)(6) 2023.Continuous dialysis was initiated on (b)(6) 2023.The pump malfunctioned and stopped working on (b)(6) 2023.The alarm read "catheter restriction".The bedside nurses attempted to trouble shoot, including changing the console and had perfusion at bedside.The patient's condition deteriorated to pea arrest and family opted for comfort measures only.Ctb 917am.The nurse reported the issue started (b)(6) 2023 at 745am.Patients iabp began alarming iabp catheter restriction, rn immediately at bedside to assess situation and pump issue, all pump lines and connections were checked and there were no kinks or lose connections.Md called to the bedside iabp pump console was switched to a different console and with continued trouble shooting efforts the iabp was unable to be restarted perfusionist and intensivist paged to bedside.Patient was reliant on support from iabp and patient began to deteriorate without the support, patient become hypotensive and unresponsive requiring the addition of vasopressor support.Acls initiated.Related balloon complaint: (b)(4).

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields; b4, d9, g3, g6, h2, h3, h6, h10.A getinge field service engineer (fse) was not dispatched to evaluate the iabp unit because the customer did not believe this to be a hardware or pump related issue.No serial numbers are available for either pump.If additional information is received, we will reopen and update the complaint.H3 other text : customer denied service.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: 18162450
• MDR Text Key: 328430673
• Report Number: 2249723-2023-04935
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 50CC - 0684-00-0576-01
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Male