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

Model Number N/A

Device Problems Gas Output Problem (1266); Pumping Problem (3016)

Patient Problem Chest Pain (1776)

Event Date 09/21/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.A getinge service territory manager (stm) was dispatched to investigate.The stm ran the iabp unit using the on-site trainer and was unable to replicate the reported failure.The stm identified multiple gas loss alarms on the logs occurring on (b)(6) 2019 from 0600-0800 hours, leading to the event date and time.The stm reported that nothing unusual was identified in the logs.The stm ran additional simulated treatments without issue.Unrelated to the reported event, the stm replaced the safety disk at 6,000,000 cycle interval and tidal disk at 12,000,000 cycle interval.The iabp unit calibrated and passed all functional and safety tests per factory specifications.The unit was returned to the customer and cleared for clinical use.The cath lab representative was briefed on the results and the unit was turned over to the biomed.No parts were replaced in connection with this event; therefore, no further investigation is required.

Event Description

It was reported that during patient therapy, iab fill was delayed.It reportedly ¿took multiple times to actually trigger the balloon to refill helium¿ while the cardiosave intra-aortic balloon pump (iabp) was connected to the patient.While ccru (critical care resuscitation unit) personnel were conducting therapy on the patient, the iabp unit kept going into standby.The unit was swapped for another and clinicians continued therapy.It was reported that the patient experienced chest pain during the swap out.The patient was transferred from ccru to ccu.No further patient harm was reported.

Event Description

It was reported that during patient therapy, iab fill was delayed.It reportedly ¿took multiple times to actually trigger the balloon to refill helium¿ while the cardiosave intra-aortic balloon pump (iabp) was connected to the patient.While ccru (critical care resuscitation unit) personnel were conducting therapy on the patient, the iabp unit kept going into standby.The unit was swapped for another and clinicians continued therapy.It was reported that the patient experienced chest pain during the swap out.The patient was transferred from ccru to ccu.No further patient harm was reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (method codes), h10.

• Brand Name: CARDIOSAVE HYBRID TUPE 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: 9166592
• MDR Text Key: 162325589
• Report Number: 2249723-2019-01611
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNDISCLOSED IAB; UNDISCLOSED IAB
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 74