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 Gas/Air Leak (2946)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.And found that the helium reservoir, high pressure regulator, regulator housing and helium tubing were all leaking.The cable for the helium regulator was corroded also.The fse replaced the 9 volt battery, helium reservoir, helium regulator, high pressure regulator, regulator housing, helium tank transducer cable, and helium tubing.The fse 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 the cardiosave intra-aortic balloon pump (iabp) had a helium leak.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.

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 a patient involved, however, no patient harm or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, b6, b7, g3, g4, g7, g8, h2, h6(investigation type, component codes & impact codes), h10, h11.Corrected fields: b5, d4(model#), d5, d11, g1(contact person), h6(clinical code).

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11230996
• MDR Text Key: 228861187
• Report Number: 2249723-2021-00147
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1