MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYP B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 12/19/2021

Event Type  Injury  

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy with a cardiosave intra-aortic balloon pump (iabp), the patient complained of abdominal pain.It was confirmed that the patient had a tendency to bradycardia and his blood pressure had decreased.It was noted that at this time, the console was frequently generating an augmentation alarm.It was then noticed that there was blood drawn into the tubing.The iab was immediately removed and therapy was concluded.The patient's abdominal pain was resolved after removal and reported to have been in stable condition.This report is for the cardiosave iabp.The iab catheter was reported in mfg report number (b)(4).

Manufacturer Narrative

Device not accessible for testing: additional information is being requested with regard to the status of the iabp.A supplemental report will be submitted when this information is provided to us.Not returned to manufacturer.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp and no blood was observed inside of the iabp unit.Also, there were no anomalies or malfunctions on the iabp unit.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

• Brand Name: CARDIOSAVE HYBRID TYP 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: 13253115
• MDR Text Key: 283778430
• Report Number: 2249723-2022-00071
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• 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: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRANSRAY PLUS 35CC30001285070681
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 40 KG