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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined: a getinge field service engineer (fse) indicated the unit was dropped or damaged by the customer.The fse provided a quote for the repair of the unit.The customer has not provided a po to repair the unit at this time.A supplemental report will be submitted upon receipt of additional information or completion of our investigation.

Event Description

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

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d10, e1 (initial reporter, event site email), g4, g7, g8, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: d5, g1 (contact person ¿ mfg site).A getinge field service engineer (fse) was dispatched to evaluate the iabp unit.Upon troubleshooting, the fse was able to locate the leak and replace the helium reservoir.The first one i had in the fse's stock did not autofill.The fse replaced the helium reservoir (0997-00-0565) with another one and this one seemed to solve the problem.The fse tested this overnight by filling the internal helium tank and then removing the console from the cart and letting it sit overnight.In the morning the internal tank was still full with no leakage.The fse then performed a complete system checkout.The unit passed all testing and was cleared for clinical use.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12747063
• MDR Text Key: 279981360
• Report Number: 2249723-2021-02546
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.