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

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse found the connector broken and replaced the fiber optic assembly, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that prior to use on a patient, the cardiosave intra-aortic balloon pump (iabp) fiber optic connection was loose.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h4, h6 (health effect-clinical codes), (type of investigation), (component codes),, (investigation conclusion), h10, h11.Corrected fields: h6 (investigation findings), (investigation conclusion).Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported 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: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110/213) the overall 12 month product complaint trend data for the period (feb-2020 through jan-2021) was reviewed.There were no triggers identified for the review period.

• 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: 11339196
• MDR Text Key: 232339969
• Report Number: 2249723-2021-00318
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1