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

Model Number N/A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

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.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 while in use on patient the cardiosave intra-aortic balloon pump (iabp) displayed an autofill complete message followed by the iabp not working.It was reported that the end user re-started the iabp, and this allowed the unit to continue working for a short period of time before the same message was displayed.It was additionally reported that while the patient was in icu the end user tried to restart the iabp to continue therapy without success, the iabp was swapped to continue therapy.No patient harm or adverse event reported.

Event Description

It was reported that while in use on patient in icu, the cardiosave intra-aortic balloon pump (iabp) displayed an autofill complete message and then stop working.It was reported that the end-user shut the iabp unit down and then restarted the unit.The iabp worked for a few minutes and then displayed the same message.The end-user then attempted to fill manually and start the pumping but the unit would not start without an error.The customer replaced the intra-aortic balloon pump (iab), restarted the iabp unit and then opted to replace the iabp with another.No patient harm or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to the customer's site.The fse evaluated the iabp and could not duplicate the alleged malfunction.The fse did not remove or installed part to the machine.The iabp was returned to the customer for clinical use.The full name of the event site is directorate of royal medical service (drms).

• Brand Name: CARDIOSAVE HYBRID
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8343121
• MDR Text Key: 137007098
• Report Number: 2249723-2019-00238
• 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: 03/12/2019

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: 01/22/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 02/17/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 80