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

Model Number 0998-00-0800-53

Device Problem Defective Component (2292)

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

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

The initial reporter named is a getinge employee who has different contact details from that of the event site.Please refer to the following email and phone number: (b)(6).

Event Description

It was reported that while performing repair of the cardiosave intra-aortic balloon pump (iabp), ordered part d103-00-0637 regulator, hi pressure,helium and received part not working properly.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The suspected faulty hi pressure helium regulator was received at getinge¿s national repair center (nrc) for evaluation.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (type of investigation), h10, h11.Corrected fields: h4.Getinge research and development (r&d) evaluated the failed part.In order to reproduce the failure r&d: the suspect high pressure helium regulator was installed in the cardiosave test fixture and r&d performed a leak test (sniffer).The unit passed.The reported failure could not be confirmed.Analysis of production: (3331) 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.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 ( apr 2019 through mar 2021) was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• 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
• MDR Report Key: 11574311
• MDR Text Key: 242423348
• Report Number: 2249723-2021-00632
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2021

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 06/09/2021; 09/17/2021
• Supplement Dates FDA Received: 07/02/2021; 10/12/2021
• Patient Sequence Number: 1