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

Model Number N/A

Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

Patient Problem Atrial Fibrillation (1729)

Event Date 09/09/2018

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was on a patient post cardiac surgery when the iabp alarmed "system over temperature" and entered shutdown mode.The patient was immediately transferred to a cs300 iabp.At the time of the event, the patient was in atrial fibrillation with a 1:1 frequency and 100% augmentation.Inotropic support was required.The staff have reported that this iabp previously had this problem and was evaluated by getinge service.The iabp was put on a trainer and left for a 24 hour period and the staff was able to replicate the alarms.Please refer to related report #2248146-2018-00568 on the intra-aortic balloon involved.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was on a patient post cardiac surgery when the iabp alarmed "system over temperature" and entered shutdown mode.The patient was immediately transferred to a cs300 iabp.At the time of the event, the patient was in atrial fibrillation with a 1:1 frequency and 100% augmentation.Inotropic support was required.The staff have reported that this iabp previously had this problem and was evaluated by getinge service.The iabp was put on a trainer and left for a 24 hour period and the staff was able to replicate the alarms.Please refer to related report #2248146-2018-00568 on the intra-aortic balloon involved.

Manufacturer Narrative

A getinge field service engineer evaluated the cardiosave iabp and it was determined that the reported failure "system over temperature" alarm is a technical alarm which specifically relates to an over temperature condition in the compressor assembly.To correct this, the scroll compressor assembly was replaced.Subsequently, the suspected defective scroll compressor was returned to getinge¿s national repair center (nrc) for part failure analysis.A technician of the nrc inspected the scroll compressor per procedure and visual damage was observed to the connector that connects into the backplane board.The connector was damaged along with damaged pins.The nrc repaired the connector for the scroll compressor and then installed the compressor in the cardiosave test fixture and tested the compressor to factory specifications per the cardiosave service manual.After extensive running of the compressor in the cardiosave test fixture, the nrc verified the error code ¿system over temperature¿ with the cardiosave shutting down.The compressor failed testing.The nrc is unable to determine the root cause of the failure.The compressor will be retained in the nrc per procedure.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was on a patient post cardiac surgery when the iabp alarmed "system over temperature" and entered shutdown mode.The patient was immediately transferred to a cs300 iabp.At the time of the event, the patient was in atrial fibrillation with a 1:1 frequency and 100% augmentation.Inotropic support was required.The staff have reported that this iabp previously had this problem and was evaluated by getinge service.The iabp was put on a trainer and left for a 24 hour period and the staff was able to replicate the alarms.Please refer to related report #2248146-2018-00568 on the intra-aortic balloon involved.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7936117
• MDR Text Key: 122794548
• Report Number: 2249723-2018-01715
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention