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 11/05/2021

Event Type  malfunction  

Event Description

It was reported that during use on a patient, two (2) cardiosave intra- aortic balloon pumps (iabp) were alarming "gas loss".The alarm lasted for two hours and it was noted there was no alarm for autofill failure.The iabp continued to support the patient and was going to be taken to the biomedical engineering department once removed from the patient.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

Type of investigation not yet determined: additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Full initial reporter name: (b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was alarming exactly two hours for "gas loss".It was also mentioned that there were no autofill failure alarms.There was no patient harm reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse did not find any problems.Therefore, the fse was unable to reproduce the reported issue.The fse then performed and passed all functional and safety tests to factory specification.The unit was then returned to the customer and 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: 12868871
• MDR Text Key: 281203032
• Report Number: 2249723-2021-02741
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• 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?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 112 KG