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

Model Number N/A

Device Problem Circuit Failure (1089)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.Upon evaluation, the iabp unit would not power on.The fse began troubleshooting that unit and discovered extensive saline contamination on boards, cables, and connections within the pump console.Notably, the logs were not available due to the extent of the damage and inability to power on the device.The fse reported that the extent of damage observed was beyond the scope of customers service agreement and an estimate for repairs was sent to the customer's biomed.The fse affixed a red sticker onto the unit indicating the device was not cleared for clinical use.The fse also obtained a loaner cardiosave iabp unit.Although the customer was presented with an estimate for the repairs of the iabp unit, however, the customer decided to decline repairs of the iabp unit involved and will be purchasing a new iabp unit.

Event Description

It was reported that prior to patient use, the cardiosave intra-aortic balloon pump (iabp) was in stand-by mode in the operation room (or), at which time, the scrub tech reportedly flushed the wrong line, and caused the iabp system to alarm and shutdown.As a result, another maquet iabp was used to perform patient therapy.There was no patient involvement, and no adverse event reported.

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 (apr 2019 through mar 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
• MDR Report Key: 11700588
• MDR Text Key: 246507365
• Report Number: 2249723-2021-00820
• 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: 07/30/2021

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: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/02/2021
• Patient Sequence Number: 1