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

Catalog Number 0998-00-0800-32

Device Problem Gas/Air Leak (2946)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm was able to reproduce the issue.The cv1 component including the o-ring were replaced.The stm 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.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a helium leak.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

During the evaluation performed by a getinge service territory manager (stm), it was observed that the cv1 component was tightened too much.The stm noted that the cv1 component has sharp edges that can tear the o-ring when overtightened.

Event Description

It was reported that while the iabp unit was in the equipment room and upon return from the weekend, the cardiosave intra-aortic balloon pump (iabp) was observed to have a helium leak.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID INT TYPE J 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: 10861938
• MDR Text Key: 217408669
• Report Number: 2249723-2020-01950
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: 10607567111117
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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: Other
• Device Catalogue Number: 0998-00-0800-32
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1