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 Mechanical Problem (1384)

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the broken fiber-optic connector and replaced it.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a damaged intra-aortic balloon (iab) port.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Updated fields: b4, b6, b7, d4 (version or model#), d11, g4, g7, h2, h4, h6 (type of investigation), h10, h11.Corrected field: a1, b5, e1 (event site email), e2, e3, g1 (contact person ¿ mfg site), g3.Analysis of production: (3331) the device history record 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

It was reported that during a routine check the cardiosave intra-aortic balloon pump (iabp) had a damaged intra-aortic balloon (iab) port.There was no patient involvement and no adverse event was reported.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11597594
• MDR Text Key: 243574704
• Report Number: 2249723-2021-00680
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1