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 Inability to Auto-Fill (1044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and verified the reported issue.The fse observed that an error occurred in three (3) items of the pneumatic module assembly (pim) test.The fse replaced the pim then conducted testing again.The iabp unit was able to complete an autofill and the pim test passed.The suspected faulty pim was then tested in another iabp unit and all testing passed.The fse then returned the original pim to the iabp unit involved and was then unable to preproduce the failure.

Event Description

It was reported that during use on a patient, while replacing the iabp unit, the end user tried to start cardiosave intra-aortic balloon pump (iabp) pumping but treatment was unable to be initiated as an automatic filling error was generated.The iabp unit was swapped out with another iabp unit to continue therapy without issue.There was no report of patient harm or injury and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, d10, g4, g7, h2, h6 (component codes), h10, h11.Corrected fields: d4 (brand name, version or model#, catalog #, unique identifier (udi)#), serial#), g1.

Manufacturer Narrative

Additional information:e1(event site postal code - (b)(6)).

Event Description

N/a.

• 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: 12684011
• MDR Text Key: 278126985
• Report Number: 2249723-2021-02442
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 02/16/2022; 03/04/2024
• Supplement Dates FDA Received: 03/10/2022; 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1