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

Model Number 0998-00-0800-32

Device Problems Overheating of Device (1437); Pumping Stopped (1503); Appropriate Term/Code Not Available (3191)

Patient Problems Cyanosis (1798); Tachycardia (2095); Ventricular Fibrillation (2130); Cardiogenic Shock (2262); Cognitive Changes (2551); Cardiovascular Insufficiency (4445)

Event Date 07/25/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

The patient evolved with worsening cardiac output (up to 2.5 l/min) when presented nausea, vomiting and in the sequence 2 episodes of seizure, brief lasting about 30 seconds, with posture in flexion of the mmss and eye movements.Ecg was run, maintaining the brd pattern (and first-degree avb), and requested troponin which was only slightly increased 0.44.After the second seizure, the patient returned making cyanosis of the extremities and liver, with a significant worsening of the pattern ventilator, so it was decided to proceed with orotracheal intubation.Patient was intubated in rapid sequence, with fentanyl, ketamine, etomidate and rocuronium, with tube 8.5, uneventful.Tube fixed at mark 22 on the labial rhyme.Having made contact with the routine and in view of the clinical worsening (intermacs 2) it was decided to pass an intra-aortic balloon through the left femoral artery.Requested and checked rx control chest for balloon positioning.After start of assistance with the balloon, 1:1, there was an improvement in the liver and pulmonary auscultation.The cardiosave intra-aortic balloon pump (iabp) unit's presented the fault "system overheating", stopped inflating the balloon and presented the fault "automatic deflation of the r wave".From then on, the system itself indicated actions that could be taken, asking to turn off the bbia, wait 10 seconds and then turn it on again.This procedure was performed three times, increasing the interval between turning off and on the bbia, in the last test the 10min interval to reconnect the bbia, all unsuccessful attempts.When turning the system back on, the system overheating fault persisted, the exhaust cooler was evaluated and it was operational.After performing the procedure of turning the bbia off and on again three times, the medical team decided to remove the balloon from the patient.After stopping therapy there was a need for increased dose of inotropic and vasopressor.Patient was sedated hypocolored hydrated eupneic acyanotic.The patient expired less than 48 hours after removal of the iabp.

Manufacturer Narrative

Getinge field service engineer (fse) was dispatched again to evaluate the iabp unit and was at first unable to reproduce the reported issue.The next day, the fse was able to reproduce the reported failure.The unit has been investigated tested and calibrated according to the procedures in the service manual.The affected unit will be sent back to the factory for root cause investigation.The equipment has not been released for clinical use.The customer will be receiving a replacement device in the interim.

Event Description

N/a.

Manufacturer Narrative

Getinge field service engineer (fse) was dispatched to evaluate the iabp unit and was unable to reproduce the reported issue.The unit has been investigated tested and calibrated according to the procedures in the service manual.No technical findings were reported and the device has been released for clinical use.

Event Description

The patient evolved with worsening cardiac output (up to 2.5 l/min) when presented nausea, vomiting and in the sequence 2 episodes of seizure, brief lasting about 30 seconds, with posture in flexion of the mmss and eye movements.Ecg was run, maintaining the brd pattern (and first-degree avb), and requested troponin which was only slightly increased 0.44.After the second seizure, the patient returned making cyanosis of the extremities and liver, with a significant worsening of the pattern ventilator, so it was decided to proceed with orotracheal intubation.Patient was intubated in rapid sequence, with fentanyl, ketamine, etomidate and rocuronium, with tube 8.5, uneventful.Tube fixed at mark 22 on the labial rhyme.Having made contact with the routine and in view of the clinical worsening (intermacs 2) it was decided to pass an intra-aortic balloon through the left femoral artery.Requested and checked rx control chest for balloon positioning.After start of assistance with the balloon, 1:1, there was an improvement in the liver and pulmonary auscultation.The cardiosave intra-aortic balloon pump (iabp) unit's presented the fault "system overheating", stopped inflating the balloon and presented the fault "automatic deflation of the r wave".From then on, the system itself indicated actions that could be taken, asking to turn off the bbia, wait 10 seconds and then turn it on again.This procedure was performed three times, increasing the interval between turning off and on the bbia, in the last test the 10min interval to reconnect the bbia, all unsuccessful attempts.When turning the system back on, the system overheating fault persisted, the exhaust cooler was evaluated and it was operational.After performing the procedure of turning the bbia off and on again three times, the medical team decided to remove the balloon from the patient.After requesting further details that may have contributed to the system overheat, it was reported the patient was tachycardic, cyanotic and hemodynamically unstable.He remained on mechanical ventilation, and was neurologically unstable with a glasgow coma scale of 3 with fixed pupils.He was supported on both inotropic and vasopressor infusions, in an irregular cardiac rhythm (¿ventricular coupling¿) with a maximal heart rate reported at 111 beats per minute.Following the ¿console overheat¿ alarm and the cessation of therapy on (b)(6) 2023 at 4:40 am, the patient was reported to require increased vasopressor and inotropic support, but remained clinically stable on low dose pressor and inotropes (norepinephrine, vasopressin and dobutamine).Seven hours following therapy cessation at 21:49 it was reported that the patient had developed ¿hemodynamic instability and refractory shock¿, with a ¿mottled¿ presentation, distal cyanosis and decreased peripheral perfusion, acute renal failure as evidenced by oliguria (270 ml in twelve hours); requiring high dose norepinephrine, vasopressin and dobutamine.It was subsequently reported that the patient expired more than 24 hours later on (b)(6) 2023 at 19:15.

• Brand Name: CARDIOSAVE HYBRID TYPE J 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: 17510837
• MDR Text Key: 320893962
• Report Number: 2249723-2023-03631
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: 10607567111117
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 7.5 FR. 34CC MAQUET BALLOON.
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 93 KG