MAUDE Adverse Event Report: DATASCOPE MAHWAH SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number CS300 INTRA-AORTIC BALLOON PUMP

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 07/27/2016

Event Type  Death  

Manufacturer Narrative

Two service representatives observed the "blood detected" alarm in the fault logs and also observed excess of condensation. No blood was present in any tubing. They verified calibration of the condensate removal module, the fan operation of crm the validated calibration of blood detector sensor. The service representatives performed both, condensate removal procedures. Significant amount of condensation noted in purge line during removal process. The iabp was tested to factory specification. It functioned normally and was returned to the customer.

Event Description

The customer reported that while the iabp was in use on a patient, the iabp generated a ¿blood back¿ alarm. No replacement iabp was used. The care giver elected to interrupt the iab therapy. No replacement pump was installed. The patient expired 5 hours later. It¿s unknown if the patient death is attributed to the reported event.

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 5835064
• MDR Text Key: 50805090
• Report Number: 2249723-2016-00023
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CS300 INTRA-AORTIC BALLOON PUMP
• Device Catalogue Number: 0998-00-3023-53
• Other Device ID Number: SI184646K0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2010
• 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: 07/29/2016 Patient Sequence Number: 1