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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided. There was no reported malfunction of the involved iabp, and the model and serial number was not provided to us. In addition, a getinge representative has advised that the iabp therapy was initiated for the treatment of reduction in blood pressure and that no anomalies or malfunction was found on the iabp unit. No repair for the iabp unit is not required, and the iabp unit is being used currently and normally at this facility. No further investigation is required. Not returned to manufacturer.

Event Description

It was reported that during intra-aortic balloon pump (iabp) therapy which was initiated on (b)(6) 2020, the iabp console generated a "gas loss in iab circuit" alarm and blood leakage was observed within the intra-aortic balloon catheter (iabc) on (b)(6) 2020. On (b)(6) 2020 the iabc was removed from the patient; however, after removal of this iabc, the patient's blood pressure was decreased temporarily. Later on, the blood pressure became stable. There was no information available about how long it took for the patient's blood pressure to be stable or whether the patient the decreased blood pressure was treated with a vasopressor agent. However, the iabp therapy ended without using a second iabc. There was no reported malfunction of the iabp and the drop in the blood pressure is not attributed to the iabp as the patient's bp dropped post iabp therapy. Refer to mfg report number 2248146-2020-00261for information on the involved iabc.

• Brand Name: CARDIOSAVE HYBRID
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10118897
• MDR Text Key: 195267859
• Report Number: 2249723-2020-00854
• Device Sequence Number: 1
• Product Code: DSP
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/04/2020 Patient Sequence Number: 1