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 Problems Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/213): the stm evaluated the iabp unit and reviewed the log files and only found multiple alarms for check iab catheter and leak in iab catheter.He suspected that there was a catheter issue as the iabp functions normally with the tester and test catheter.He thinks that the customer must have figured out what was going on as they continued to use the unit on the patient for several days afterwards with no alarms.The unit passed all functional tests and validated calibration.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient the cs300 intra-aortic balloon pump (iabp) was alarming.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, e2, e3, g4, g7, h2, h4, h6 (type of investigation), h10, h11 corrected fields: h6 (medical device ¿ problem code).Historical data analysis: (4109/114) 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: (4110/114) the overall 24 month product complaint trend data for the period (nov 2019 through oct 2021) was reviewed.There were no triggers identified for the review period.Analysis of production: (3331/114) 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.

Manufacturer Narrative

Corrected fields: h6 (investigation findings).

• 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12797250
• MDR Text Key: 280776963
• Report Number: 2249723-2021-02602
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2022

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 11/17/2021; 06/14/2022
• Supplement Dates FDA Received: 12/14/2021; 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON CATHETER