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

Model Number N/A

Device Problems No Audible Alarm (1019); Backflow (1064); 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 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.Getinge service has not been requested in connection with this event.However, the facility's biomedical department personnel has advised that on the day of the event, the unit was scheduled for a preventative maintenance (pm).Subsequently, they were able to perform the pm after the iabp support was discontinued on this patient.The biomed that performed the pm has provided us with the fault logs and indicate that the logs did not show anything of note.It appears that the unit has been returned to clinical use after the pm, but we have requested confirmation of this.A supplemental report will be submitted if we receive this additional information.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) experienced a blood back event.It was noted by the intensive care unit (icu) nurse that there was blood in the helium extender tubing but the iabp unit did not alarm or go into standby.The physician requested to know why the unit did not alarm at the time of the event.There was no patient harm and no adverse event was reported.

Manufacturer Narrative

The facility's biomedical engineer has advised that the iabp was returned to clinical use.No further investigation is required.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) experienced a blood back event.It was noted by the intensive care unit (icu) nurse that there was blood in the helium extender tubing but the iabp unit did not alarm or go into standby.The physician requested to know why the unit did not alarm at the time of the event.There was no patient harm and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8580720
• MDR Text Key: 144162566
• Report Number: 2249723-2019-00737
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/04/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1