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 Appropriate Term/Code Not Available (3191)

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

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that post patient care the cardiosave intra-aortic balloon pump (iabp) failed the pim leak test.There was no patient involvement.

Manufacturer Narrative

It was reported that post patient care the cardiosave intra-aortic balloon pump (iabp) failed the pim leak test.There was no patient involvement, and no adverse event reported.There was no patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.He states that cathlab personnel identified unit as failing the pim leak test, post patient care.Cathlab turned over unit to biomed for resolution.Successfully completed a simulated treatment with testing catheter and trainer without issue upon initially testing the unit.Unit however failed the all manifold, pim section, 4th test, thus pointing to the safety disk membrane.The all manifold test however, successfully completed, other than the aforementioned.Replaced suspect safety disk and successfully completed an all manifold test without issue.Unit calibrated and passed all functional and safety tests per factory specifications.Returned to customer and cleared for clinical use.The nrc verified the failure of the safety disk failure of the membrane differential pressure with the results of 7 mmhg.Factory specification is +/- 6mmhg.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

• 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: 15005705
• MDR Text Key: 304599476
• Report Number: 2249723-2022-01680
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• 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?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1