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

Model Number N/A

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

When a getinge service territory manager (stm) was dispatched to evaluate the iabp for another reported issue (mfg report number.2249723-2020-01297) , the stm did not have any iab disconnect issues when completing the repair.The stm performed all calibration, functional, and safety checks to meet factory specifications.Unit passed all calibration, functional, and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during use on a patient, an icu rn called to report that the end user changed a cardiosave intra-aortic balloon pump (iabp), which had alarmed for ¿over temperature¿.It had also alarmed for "iab disconnected", but nothing was disconnected.The alarm did not continue on the second console.No patient harm, serious injury, or adverse event was reported.

Manufacturer Narrative

Updated fields: h6 (evaluation method codes).

Event Description

It was reported that during use on a patient, an icu rn called to report that the end user changed a cardiosave intra-aortic balloon pump (iabp) which had alarmed for ¿over temperature¿.It had also alarmed for "iab disconnected", but nothing was disconnected.The alarm did not continue on the second console.No patient harm, serious injury or adverse event was reported.This report is for the iab disconnected issue.The over temperature issue was reported under mfg report number 2249723-2020-01297.

• 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 07430
• MDR Report Key: 10785381
• MDR Text Key: 214576740
• Report Number: 2249723-2020-01818
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 50CC SENSATION PLUS; 50CC SENSATION PLUS
• Patient Age: 57 YR
• Patient Weight: 88