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

Model Number N/A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Myocardial Infarction (1969)

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.

Event Description

It was reported that therapy with a cardiosave intra-aortic balloon pump (iabp) was started on a patient with an acute myocardial infarction (ami), in an emergency case.The iabp generated an ¿overheat¿ alarm.The customer restarted the unit and pumping resumed normally.The following day, the iabp was replaced to continue therapy.It was noted that pumping was stopped for 5 minutes during the replacement of the unit.There was no patient injury or adverse event reported.

Manufacturer Narrative

***in relation to the update made in this current follow up #1 mdr, field was updated with an incorrect serial number.However, the field is no longer open to the writer to make the correction.Note that the correct serial number is (b)(4) and not the one reflected in d4 field.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.A getinge field service engineer (fse) evaluated the iabp and performed running test.The fse was able to duplicate the reported issue and observed that the surface temperature of the iabp after the running test was approximately 56 degrees celsius.To resolve the issue, the fse replaced the scroll compressor and again performed running test and there was no re-occurring problem.The iabp was returned to the customer and cleared for clinical use.

Event Description

It was reported that therapy with a cardiosave intra-aortic balloon pump (iabp) was started on a patient with an acute myocardial infarction (ami), in an emergency case.The iabp generated an ¿overheat¿ alarm.The customer restarted the unit and pumping resumed normally.The following day, the iabp was replaced to continue therapy.It was noted that pumping was stopped for 5 minutes during the replacement of the unit.There was no patient injury or adverse event reported.

Manufacturer Narrative

The scroll compressor was returned to getinge national repair center (nrc) for further evaluation per policy due to the reported event of "overheating alarm".A getinge engineer inspected the scroll compressor and no visual damage was observed.The scroll compressor was then installed into cardiosave test fixture and tested to factory specification per service bulletin sb (b)(4) and cardiosave service manual.The nrc could not reproduce ¿overheat¿ alarm and the scroll compressor passed testing.The nrc is retaining the scroll compressor per procedure.

Event Description

It was reported that therapy with a cardiosave intra-aortic balloon pump (iabp) was started on a patient with an acute myocardial infarction (ami), in an emergency case.The iabp generated an ¿overheat¿ alarm.The customer restarted the unit and pumping resumed normally.The following day, the iabp was replaced to continue therapy.It was noted that pumping was stopped for 5 minutes during the replacement of the unit.There was no patient injury or adverse event reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7498386
• MDR Text Key: 107972558
• Report Number: 2249723-2018-00787
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• 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-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1