MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a system over temperature alarm.A getinge emergency support consultant (esc) advised the end user to follow the iabp "help" menu.The end user powered down the iabp unit for ten (10) seconds and then turned the iabp unit back on as per the help menu.It was noted that the issue was resolved for a few hours before the system over temperature alarm was repeated.The esc suggested the end user swap out the iabp unit with another iabp unit, but the customer indicated that no additional iabp unit's were available at the time.The esc had the end user obtain a 3-way stopcock and luer-lock 30 or 60cc syringe for manual inflation of the intra-aortic balloon (iab) incase the iabp unit failed before the user was able to swap out the iabp unit.The iabp unit would be sent to the customer's biomed as soon as possible.There was no reported malfunction on the reported intra-aortic balloon(iab).A separate report will be submitted on the cardiosave iabp.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a system over temperature alarm.A getinge emergency support consultant (esc) advised the end user to follow the iabp "help" menu.The end user powered down the iabp unit for ten (10) seconds and then turned the iabp unit back on as per the help menu.It was noted that the issue was resolved for a few hours before the system over temperature alarm was repeated.The esc suggested the end user swap out the iabp unit with another iabp unit, but the customer indicated that no additional iabp unit's were available at the time.The esc had the end user obtain a 3-way stopcock and luer-lock 30 or 60cc syringe for manual inflation of the intra-aortic balloon (iab) incase the iabp unit failed before the user was able to swap out the iabp unit.The iabp unit would be sent to the customer's biomed as soon as possible.There was no reported injury to the patient.There was no reported malfunction on the reported intra-aortic balloon(iab).A separate report will be submitted on the cardiosave iabp.Clarifying information: ***an initial emdr for this complaint was incorrectly submitted.This mdr was submitted on the basis of patient injury; however, we have received clarifying information that there is no patient harm or death.As a result, an initial mdr is not necessary, and this complaint will be cancelled in our database.Please cancel in your database.Refer to mfg report # 2249723-2020-01481 for all information and investigation findings on this complaint event.

Manufacturer Narrative

An initial emdr for this complaint was incorrectly submitted.This mdr was submitted on the basis of patient injury; however, we have received clarifying information that there is no patient harm or death.As a result, an initial mdr is not necessary, and this complaint will be cancelled in our database.Please cancel in your database.Refer to mfg report # 2249723-2020-01481 for all information and investigation findings on this complaint event.

• Brand Name: UNKNOWN IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10522741
• MDR Text Key: 206564994
• Report Number: 2248146-2020-00464
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE CH279396E8; CARDIOSAVE CH279396E8
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 65