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

Model Number N/A

Device Problems Inflation Problem (1310); Inaccurate Synchronization (1609)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

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.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) would not augmentate and the intra-aortic balloon (iab) was not inflating.The patient's heart rate was noted to be 90-100 beats per minute (bpm) and no kinks were noted.In addition, the nurse noted during pre-surgery and post-surgery, the iab appeared to not be fully inflating via the icon on the screen.Possible causes were reviewed with no solid conclusion.The diastolic augmentation was lower than the systolic pressure and possible causes were reviewed again with no clear conclusion.The patient did fine and the iab was removed as scheduled.There was no patient harm and no adverse event was reported.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) would not augmentate and the intra-aortic balloon (iab) was not inflating.The patient's heart rate was noted to be 90-100 beats per minute (bpm) and no kinks were noted.In addition, the nurse noted during pre-surgery and post-surgery, the iab appeared to not be fully inflating via the icon on the screen.Possible causes were reviewed with no solid conclusion.The diastolic augmentation was lower than the systolic pressure and possible causes were reviewed again with no clear conclusion.The patient did fine and the iab was removed as scheduled.There was no patient harm and no adverse event was reported.

Manufacturer Narrative

A getinge service territory manager (stm) evaluated the iabp and was unable to duplicate the problem after putting the unit to run on trainer for one hour.In addition, there were no errors or alarms in the fault logs, and the stm determined that there was no failure of the unit.No parts were replaced and all safety, functionality, and calibration checks were completed.Subsequently, the stm performed preventative maintenance (pm) service on the unit and completed all functional and safety tests which passed per factory specifications.The iabp unit was returned to the customer and cleared for clinical use.

• 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: 8533530
• MDR Text Key: 142634266
• Report Number: 2249723-2019-00642
• 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: 05/21/2019

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?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 120