MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems No Audible Alarm (1019); Leak/Splash (1354); 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 12/08/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.The authorized getinge distributor reported that no alarm were found in the error logs related to the iab leakage or blood back.The iabp unit is still faulty and has not yet been returned to the customer for clinical use.Additional information has been requested, and we will report accordingly when it becomes available.The full name of the event site is (b)(6).

Event Description

It was reported that during use on a patient, a maquet intra-aortic balloon (iab) 40cc was used with the cardiosave intra-aortic balloon pump (iabp), and during therapy the iab had a leak and at this time the iabp did not stop.It was also found that no blood detection alarm error occurred, resulting blood going into safety disk and related pneumatic circuits.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

It was reported that technician of the authorized getinge distributor evaluated the iabp unit and found blood had leaked into the side of the pneumatic circuit through the safety disk and damaged the iabp¿s electronic component levels.The board and pneumatic circuit were affected with the blood intrusion.To address the issue, the technician replaced the safety disk, power management board and helium fill manifold assembly with new ones and checked their function.Following the repair, the iabp unit was functioning and in good working condition.The iabp has been returned to the customer and cleared for clinical use.

Event Description

It was reported that during use on a patient, a maquet intra-aortic balloon (iab) 40cc was used with the cardiosave intra-aortic balloon pump (iabp), and during therapy the iab had a leak and at this time the iabp did not stop.It was also found that no blood detection alarm error occurred, resulting blood going into safety disk and related pneumatic circuits.No patient harm, serious injury or adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE G PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8252464
• MDR Text Key: 133322450
• Report Number: 2249723-2019-00092
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• 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: 06/10/2019

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: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 12/25/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 86