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

Model Number N/A

Device Problems Off-Label Use (1494); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) called and spoke to the contact person of the biomed department and confirmed that the pump was operating properly.The customer also reported that the tank and screen of the iabp unit showed that the tank was full on the external gage.The customer reported to have found that the helium tank had not been turned which resulted in the reported issue.As such, the customer did not request service on the pump and no service was performed.Furthermore, the getinge fse completed a preventative maintenance (pm) on friday, 08oct2020.

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) had a helium issue.It was further reported that the customer attempted to troubleshoot the unit, as well as changed the helium tank at 1/4.However, after replacing each helium tank, the unit's screen would only register 1/4.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during off-label use via axillary insertion, the cardiosave intra-aortic balloon pump (iabp) had a helium issue.It was further reported that the customer attempted to troubleshoot the unit, as well as changed the helium tank at 1/4.However, after replacing three (3) helium tanks, the unit's screen would only register 1/4.No patient harm, serious injury or adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE 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: 10803695
• MDR Text Key: 218938086
• Report Number: 2249723-2020-01850
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• 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: 01/05/2021

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: 0998-00-0800-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS SN#(B)(6)
• Patient Age: 65 YR
• Patient Weight: 117