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

Model Number N/A

Device Problems No Audible Alarm (1019); Display or Visual Feedback Problem (1184); Loss of Power (1475); Device Contamination with Body Fluid (2317)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer 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 cs100 intra-aortic balloon pump (iabp) was running normally and at approximately 3:00 am in the morning, the nurse found blood in the balloon catheter.However, the iabp continued to pump, but the unit did not sound an alarm.The customer immediately shutdown the iabp and informed the physician to pull the balloon catheter.The doctor implanted another balloon and replaced another machine.There was no patient harm or serious injury reported.

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) was running normally and at approximately 3:00 am in the morning, the nurse found blood in the balloon catheter.However, the iabp continued to pump, but the unit did not sound an alarm.The customer immediately shutdown the iabp and informed the physician to pull the balloon catheter.The doctor implanted another balloon and replaced another machine.There was no patient harm or serious injury reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported "blood back with no alarm" issue.The fse administered a safety disk leak test with no resulting failure.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8489160
• MDR Text Key: 141186172
• Report Number: 2249723-2019-00556
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 59