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

Model Number N/A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp and was unable to find blood inside the unit.The fse determined that it was a false alarm due to a leak at the exhaust end.The iabp was returned to the customer and cleared for clinical use.Full event site name: (b)(4).

Event Description

It was reported that while in use on a patient the cs100 intra-aortic balloon pump (iabp) "blood detected".The nurse immediately checked the balloon and extension tube and found no blood.It is unknown if there was harm or injury to patient; however no adverse event was reported.

Manufacturer Narrative

Please refer to the following complete result evaluation of the getinge field service engineer (fse): a getinge field service engineer (fse) evaluated the iabp and was unable to find blood inside the iabp unit.The fse determined that it was a false alarm due to a leak at the exhaust end in blood detect tube.To fix the leak issue, the fse reconnected the filling tube between the safety disk and the fill manifold.The iabp was then returned to the customer and cleared for clinical use.

Event Description

It was reported that while in use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed "blood detected".The nurse immediately checked the balloon and extension tube and found no blood.There was no harm or injury to patient and no adverse event was reported.

• 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: 9535796
• MDR Text Key: 190763650
• Report Number: 2249723-2019-02123
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose