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

Model Number 0998-00-0800-65

Device Problem Inability to Auto-Fill (1044)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of repair service.The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.(b)(6).

Event Description

It was reported that during pre-delivery inspection, the cardiosave intra- aortic balloon pump (iabp) had a fill manifold failure.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able confirm the malfunction of helium reservoir assembly.The fse replaced the helium reservoir assembly and the issue was resolved, unit passed all functional and safety tests per factory specifications.The iabp was returned to customer and cleared for clinical use.

Event Description

It was reported that during pre-delivery inspection, the cardiosave intra- aortic balloon pump (iabp) had a fill manifold failure.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10.A senior repair technician of the national repair center (nrc) installed the helium reservoir into the cardiosave test fixture and tested the assembly to factory specifications per procedure and the cardiosave service manual.The senior repair technician installed the helium reservoir into the cardiosave test fixture and tested the assembly to factory specifications.The technician could not verify the failure of the fill manifold test failing.The technician performed the all manifold test numerous times with no trouble found.The assy, helium reservoir passed testing.The helium assembly was sent to production per procedure.

Manufacturer Narrative

The nrc received the assy, helium reservoir from the getinge production department.Production could not verify the failure of the reservoir failing the fill valve test.No trouble was found.The reservoir passed testing.The national repair center installed the reservoir into the cardiosave test fixture and tested the reservoir to factory specifications per the cardiosave service manual.The reservoir passed testing.Retaining the reservoir in the nrc per procedure.

Event Description

N/a.

Manufacturer Narrative

Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.Analysis of production records: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.

• 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: 11380832
• MDR Text Key: 233745675
• Report Number: 2249723-2021-00419
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/02/2021

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: 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?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/09/2021; 07/14/2021; 08/12/2021; 11/02/2021
• Supplement Dates FDA Received: 04/27/2021; 08/05/2021; 09/03/2021; 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1