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 Device Alarm System (1012)

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

Event Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed a gas loss alarm.The customer reported the iab was an axillary insertion and noted a chest x-ray revealed good placement.The customer placed the getinge representative on speakerphone so a dr.Who identified himself as (b)(6) could also interact.I reviewed the off-label use of the product and that i could continue to assist as from a femoral approach.The getinge representative reviewed checking for blood in the helium tubing and verifying that all connections secured on every occurrence of the alarm.Dr.(b)(6) stated the positional nature of the alarm.We also reviewed the option of lowering the augmentation bars by 1-2 in order to reduce the sensitivity of the alarm.They were both very thankful for the assistance.(b)(6) gave the necessary information for a complaint and biohazard return box to be sent.Pt is (b)(6) yo m 5¿8¿ (b)(6) lbs no patient harm, serious injury or adverse event was reported.Original balloon complaint (gas loss in iab circuit) reported in separate report mfg# 2248146-2021-00515.

Event Description

N/a.

Manufacturer Narrative

A getinge representative was not dispatched to evaluate the device because no repair of the iabp has been requested.The customer reported that that iabp was discarded after use and does not have any other information.Patient height: 5'8" h3 other text : evaluation not requested by complainant.

• 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: 12328492
• MDR Text Key: 266889863
• Report Number: 2249723-2021-01830
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION 7FR 40CC
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 93 KG