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

Model Number 0998-00-3023-53

Device Problem Inability to Auto-Fill (1044)

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) customer called for help troubleshooting a pump alarming "autofill failure" it has reportedly been working fine all day until several minutes ago.The insertion site is femoral and there is no visible blood or kink in the helium tubing.The pump has been in standby for 15 minutes.Customer was walked through steps to press the "fill" key, and they dropped the augmentation several bars without relief.An attempt to tilt the patient while pressing fill was unsuccessful.The helium tubing was removed and reconnected in an attempt.At this point customer tried switching to another pump and this was successful.Pumping has been resumed alarm free and the patient is stable.

Manufacturer Narrative

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

Manufacturer Narrative

Updated data: b4,g3,g6,h2,h10,h11.Corrected data: b5, d4 (serial).

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) customer called for help troubleshooting a pump alarming "autofill failure" it has reportedly been working fine all day until several minutes ago.The insertion site is femoral and there is no visible blood or kink in the helium tubing.The pump has been in standby for 15 minutes.Customer was walked through steps to press the "fill" key, and they dropped the augmentation several bars without relief.An attempt to tilt the patient while pressing fill was unsuccessful.The helium tubing was removed and reconnected in an attempt.At this point customer tried switching to another pump and this was successful.Pumping has been resumed alarm free and the patient is stable.There was no patient harm reported.

Event Description

Record cancelled as duplicate of tw# (b)(4) mfg # 2249723-2023-02571.

Manufacturer Narrative

Record cancelled as duplicate of (b)(4).Mfg # 2249723-2023-02571.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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: 17020985
• MDR Text Key: 316132838
• Report Number: 2249723-2023-02586
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/20/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GETINGE LINEAR 40CC.; UNKNOWN.
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 64 KG