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

Model Number N/A

Device Problem Restricted Flow rate (1248)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this reported event.The getinge field service engineer (fse) advised that the local authorized distributor's engineer performed service repairs to the unit involved in this reported event.Based on the information available at this time, the local distributor's engineer confirmed the reported issue in the logs upon booting the iabp unit into engineering mode.The local distributor's engineer disassembled the safety disk to confirm the internal condition, and at that time, confirmed no signs of blood in the internal pipeline.After re-installation, the iabp unit tested normally and the ecg/bp trigger also tested normal.The fse then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.The initial reporter (b)(6) is a getinge authorized local dealer engineer who has different contact details from that of the event site.

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) alarmed iab catheter restriction.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/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: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period (apr-2019 through mar-2021) was reviewed.There were no triggers identified for the review period.

• 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
• MDR Report Key: 11734040
• MDR Text Key: 247689772
• Report Number: 2249723-2021-00878
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2021
• Patient Sequence Number: 1