MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/213): a getinge field service engineer (fse) was dispatched to investigate.The fse arrived on site and was able to reproduce the reported issue.Upon inspection, the fse observed the lower level output blood pressure (llobp) connector pins to be completely detached from their solder points.The fse resolved the issue by replacing the front end board.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter that is abbreviated is stephanie ingram.

Event Description

It was reported that prior to use, the low level input connector on the cardiosave intra-aortic balloon pump (iabp) was found loose, resulting in the low level output blood pressure to not be displayed.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6, h10, h11.Corrected fields: g1, h6(component code).Analysis of production: (3331) the device history record 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.Historical data analysis: (4109) 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) the overall 24 month product complaint trend data for the period sep 2019 through aug 2021 was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• 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: 12416486
• MDR Text Key: 270635832
• Report Number: 2249723-2021-01994
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1