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 Problem Device Contamination with Body Fluid (2317)

Patient Problems Abdominal Pain (1685); Insufficient Information (4580)

Event Date 05/15/2023

Event Type  Injury  

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) units balloon ruptured.

Event Description

It was reported that during use , the cs300 intra-aortic balloon pump (iabp) this iabp this unit was used as the second device was used with a non-maquet balloon.The balloon of the non-maquet iab catheter was perforated/ruptured and blood was entering into the first iabp unit.The extender tubing of the non-maquet iab catheter was disconnected from the first iabp unit.However, later on, when the non-maquet iab catheter was about to be removed percutaneously from the patient, a clinical engineer connected misguidedly its extender tubing to this iabp unit.Blood was also aspirated in this iabp unit.The extender tubing was disconnected from this iabp unit.Although the nonmaquet iab catheter was attempted to be removed from the patient, it was hard to remove percutaneously.Therefore surgical intervention was performed in order to remove the non maquet iab catheter from the patient.After removal of the non-maquet iab catheter, the patient experienced abdominal pain.Iabp therapy ended and the patient has been monitored.Related complaint: (b)(4) - mfg report # 2249723-2023-02557.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse confirmed that there was blood contamination in the crm (iab port) and that no blood contamination was observed visually or with a cotton swab on internal equipment or safety discs.So, in order to fix the issue, the fse replaced the crm.The unit was then released for use.

• 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: 17009915
• MDR Text Key: 316010028
• Report Number: 2249723-2023-02557
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TOKAI BALLOON 30CC
• Patient Outcome(s): Required Intervention