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 Problems Inability to Auto-Fill (1044); Appropriate Term/Code Not Available (3191)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined|4118: a supplemental report will be submitted upon completion of our investigation.The full name of the event site was shortened due to field character limit.The full name is: (b)(6) medical center.

Event Description

It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, b5, g4, g7, g8, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: d5, g1 (contact person ¿ mfg site), h6 (medical device ¿ problem code).A getinge field service engineer (fse) evaluated the cardiosave intra-aortic balloon pump (iabp), but was unable to reproduce the reported issue.However, the fse was able to verify the alarms in the iabp¿s diagnostic error log.The fse disassembled the unit, to check for any pinched or blocked helium or vacuum lines and found no issues, then reassembled the unit and the iabp was able to pass all the leak tests, and the fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.

Event Description

It has been reported that during training the cardiosave intra-aortic balloon pump (iabp) unit displayed a autofill failure error.There was no patient involvement and no adverse event was reproted.

• 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: 12821739
• MDR Text Key: 284012866
• Report Number: 2249723-2021-02640
• 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: 08/04/2022

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1