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

Model Number N/A

Device Problem Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge authorized distributor field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and found that the negative pressure value of the system was abnormal.To fix the issue, the fse replaced the filter pressure and filter vacuum.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.(b)(6).

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed "machine may need maintenance" and "system temperature is too high," thereafter.No patient harm, serious injury or adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Analysis of production: (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.Historical data analysis: (4109/213) 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: (4110/213) the overall 24 month product complaint trend data for the period (enter timeframe) was reviewed.There were no triggers identified for the review period.

• Brand Name: CARDIOSAVE HYBRID TYPE I 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: 11333883
• MDR Text Key: 232337019
• Report Number: 2249723-2021-00293
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• 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
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.