MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-65

Device Problems Defective Alarm (1014); Inability to Auto-Fill (1044); Device Contamination with Body Fluid (2317)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2023

Event Type  Death  

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a non-datascope balloon rupture.

Manufacturer Narrative

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

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) a non-maquet iab catheter was being connected to this iabp unit during iabp therapy.The balloon of the concomitant iab catheter was perforated/ruptured, and blood was observed within the extender tubing of the concomitant iab catheter.Then, blood was entering into this iabp unit.Reportedly, no alarm was generated when the balloon of the concomitant iab catheter was perforated/ruptured.On the same day, 10:36 a.M.(approximately 2 hours after blood was observed within extender tubing), an alarm "autofill failure" was emitting and pumping stopped.Then the iab catheter was decided to be removed from the patient and this iabp unit was disconnected from the iab catheter.Attempt to remove the concomitant iab catheter was made; however it was unable to be removed percutaneously from the patient.Therefore surgical intervention was performed.Later on, the patient was transferred urgently to another facility.The patient expired.

Manufacturer Narrative

Updated data: b4,g3,g6,g2,h6(problem code),h10,h11 corrected data: b1,b2,b3,b5,e1(name),e3,h1,h6(clinical & impact).

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse replaced the following parts due to the blood back: crm, blood detect tubing, fill manifold brkt, purge valve assembly, fill manifold assembly and, hose barb.The fse then stated that after replacing the parts, the operation test was conducted.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• 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: 16903985
• MDR Text Key: 315009035
• Report Number: 2249723-2023-02307
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: 10607567108322
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063525
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 05/29/2023; 09/28/2023
• Supplement Dates FDA Received: 06/09/2023; 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TOKAI MEDICAL PRODUCTS
• Patient Outcome(s): Death
• Patient Sex: Male