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 Device Emits Odor (1425); Device Contamination with Chemical or Other Material (2944)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit' saline bag bursted into unit.

Manufacturer Narrative

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

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) unit' saline bag bursted into unit and gave off a burning smell.There was no patient harm.

Manufacturer Narrative

Additional information: e1(event site telephone: (b)(6).It was reported that the cardiosave intra-aortic balloon pump (iabp) had an issue which occurred during use, saline bag bursted into unit.A getinge field service engineer (fse) evaluated the unit end user reported burning smell and confirmed saline spill over cardiosave console.Fse replaced power management, motor control & thermal recorder pcba, cardiosave rohs power management, pcb,motor control,rohs and printer,thermal,xe-50b,custom) pcbas all contaminated.All assemblies were replaced.Device passed all calibration, performance and electrical safety tests according to factory specifications.The fse performed a full pm.The unit passed all tests and was returned to the customer for clinical use.There was a patient involvement but no harm reported.The defective components were received for further investigation.The failure analysis and testing dept.Received the following parts associated with this complaint with the failure being reported as saline damage: pn 0161-00-0024-04 rev.C, sn (b)(6) - saline damage confirmed pn 0670-00-1162, - saline damage confirmed pn 0670-00-1159, saline damage confirmed fat will not install and test these parts due to the risk associated to the cardiosave test fixture.Fat verified the saline damage on each of these parts but no root cause identified.Retaining the parts in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to define.

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: 18633077
• MDR Text Key: 334515033
• Report Number: 2249723-2024-00429
• 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,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1