MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

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

Patient Problem Injury (2348)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.The hospital has advised that hey did not identify the iabp involved in the event and they cannot provide the status of this iabp.No further information is available, and no further investigation is required as there was no reported malfunction of the iabp.(b)(6).Not returned to manufacturer.

Event Description

It was reported that the nurse observed blood in the intra-aortic balloon (iab) catheter.The doctor was warned.The patient was weaned quickly and the iab catheter was removed.The product was tested and a leak was detected in the balloon.It was reported that this failure caused the fall of the volume of systolic ejection.The serial number of the involved cs100 intra-aortic balloon pump (iabp) was not provided; however, the customer indicated that the iabp displayed a visual alarm.It was also reported that there was no deterioration in the patient¿s health due to the event.The related iab complaint has been submitted under mfg report# 2248146-2019-00424.

• Brand Name: CS100
• 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: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8634062
• MDR Text Key: 145904213
• Report Number: 2249723-2019-00841
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening