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

Model Number N/A

Device Problem Gas Output Problem (1266)

Patient Problems Cardiac Arrest (1762); Cardiogenic Shock (2262); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2021

Event Type  Death  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during patient therapy, the cardiosave intra-aortic balloon pump (iabp) alarmed ¿gas gain in iab circuit.¿ additionally and unrelated, it was reported that the iabp unit alarmd ¿gas loss in iab circuit." it was further reported that while iabp unit alarmed "gas loss in iab circuit," the screen went black and the unit suddenly shutdown.No patient harm, serious injury or adverse event was reported.

Event Description

Additional information received 02-may-2021.It was later reported that during intra-aortic balloon (iab) therapy, the console was connected to the power supply and stopped augmenting.There had not been any earlier sign of dysfunction, alarm, and no change in settings.The console then generated a gas gain alarm.The connections were all checked and secured.The customer noted that there was no option to retry other software escapes.While the customer was searching for the helium tank, the screen on the console went black while still generating an alarm.During this time, the patient was stable and the iab was removed after five minutes.The iabp was restarted by hard reset and showed no indication of low battery and had an adequate helium gas supply.After stopping iabp, then 10 hours later the patient suddenly went into pea cardiac arrest, resuscitation failed, patient died.Please refer to related mfg report number 2248146-2021-00223 on the involved intra-aortic balloon (iab).

Manufacturer Narrative

Event site postal code: (b)(6).A getinge field service engineer (fse) contacted the biomedical engineer from the umcg hospital and it has been decided not to repair the iabp because of the associated costs, the unit is no longer deployed.The unit has been decommissioned and will not be used clinically.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (type of investigation), h10, h11.Corrected fields: h6 (investigation conclusion).Historical data analysis: (4109/4247) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110/4247) the overall 24 month product complaint trend data for the period (apr 2019 through mar 2021) was reviewed.There were no triggers identified for the review period.Analysis of production: (3331/4247) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID INT TYPE E/F 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11627628
• MDR Text Key: 244209897
• Report Number: 2249723-2021-00721
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 50CC INTRA-AORTALE BALLOON, IAB
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Female