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

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and the o-ring on the rear of the pump console was found to be broken.The o-ring was replaced to fix the issue, and two new helium tanks were provided as a customer courtesy.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all 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 an in-service training performed by a getinge clinical representative, it was observed that the brand new helium tank on the cardiosave intra-aortic balloon pump (iabp) was completely empty.When the tank was replaced with a full one, there was an audible helium leak.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6, h10.The device history record (dhr) for this iabp was reviewed and no non-conformances related to the reported event were noted.

Event Description

It was reported that during an in-service training performed by a getinge clinical representative, it was observed that the brand new helium tank on the cardiosave intra-aortic balloon pump (iabp) was completely empty.When the tank was replaced with a full one, there was an audible helium leak.There was no patient involvement, and no adverse event reported.

• 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: 11344990
• MDR Text Key: 232616704
• Report Number: 2249723-2021-00325
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1