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

Model Number 0998-00-0800-65

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

The getinge field service engineer (fse) replaced the regulator, high pressure, helium in order to resolve the leakage.However, the unit is still undergoing repairs at getinge service center with respect to an unrelated and additional issue.(b)(6).The initial reporter named is a getinge employee who has different contact details from that of the event site.

Event Description

It was reported that while servicing a unit during a pre-delivery inspection, the getinge field service engineer (fse) found that the cardiosave intra-aortic balloon pump (iabp) had a leakage from the high pressure regulator.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to the customer's site.The fse replaced helium reservoir, helium regulator which resolved the issue.The fse performed preventive maintenance and the iabp passed all calibration, functional and safety test and was returned to customer and cleared for clinical use.

Manufacturer Narrative

The suspected faulty regulator, high pressure, helium was received at getinge's national repair center (nrc).When additional information is received, a supplemental report will be submitted.

Event Description

N/a.

Manufacturer Narrative

In order to reproduce the failure, the suspect high pressure helium regulator was installed in the cardiosave test fixture at the national repair center(nrc).A leak test (sniffer) (seq.28 of 0998-00-0800m01_ae) was performed and passed.

Event Description

It was reported that while servicing a unit during a pre-delivery inspection, the getinge field service engineer (fse) also found that the cardiosave intra-aortic balloon pump (iabp) had a leakage from the high pressure regulator.There was no patient involvement reported.Related to original complaint: (b)(4) - (fill manifold test failure).

• Brand Name: CARDIOSAVE HYBRID INT TYP B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11821743
• MDR Text Key: 251197412
• Report Number: 2249723-2021-01007
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2249723-01/24/2023-003-C
• Patient Sequence Number: 1