MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-65

Device Problems Backflow (1064); Restricted Flow rate (1248); Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after one day of intra-aortic balloon (iab) therapy, the cs100 intra-aortic balloon pump (iabp) frequently generated a check iab catheter alarm.The drive tube outside the body was checked, but there was no blood seen.Since the alarm occurred again the next day, the iabp was switched to a cs300.Blood was then seen in the tubing and entered the iabp.Therapy was completed so the iab was removed.There was no patient harm or adverse event reported.Related to balloon complaint tw (b)(4).

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse stated that the alarm was caused by the damage of the concomitant iab catheter and not the unit itself.Also due to the damaged concomitant iab catheter, blood was entered into the console of the unit.In order to solve the issue, the fse replaced the following parts: safety disk, condensate removal module (crm), purge valve assembly, and blood detect tubing.The fse then stated that the repair was completed.

• Brand Name: CS100 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: 16777655
• MDR Text Key: 314040444
• Report Number: 2249723-2023-02016
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: 10607567107684
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031636
• 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
• Type of Report: Initial,Followup
• Report Date: 08/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 08/12/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRANSRAY 34CC BALLOON.