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

Model Number 0998-00-0800-65

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and found that the solenoid valves of k4 and k10 were bad.The fse replaced the parts and confirmed that there was no problem.The iabp was returned to the hospital.

Event Description

It was reported that during inspection after first use of the cardiosave intra-aortic balloon pump (iabp).A leak test was performed and it did not pass.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device: (10/213): the pneumatic module assy,rohs was returned to the manufacturer for further evaluation.A senior repair technician of the national repair center (nrc) installed the module into the cardiosave test fixture and tested the module to factory specifications and to the cardiosave service manual.The technician verified the failure of a leak in the pneumatic module.The module failed the leak differential test.The pneumatic module was sent to production for failure analysis per procedure.The national repair center received the pneumatic module assy,rohs.Production performed a failure only analysis, verified the failure and found valve k4 leaking.Valve k4 was defective.Retaining the pneumatic module in the national repair center per procedure.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (type of investigation), h10, h11.Corrected field: d1, d4 (version or model #, catalog #, unique identifier (udi) #), g1 (contact person ¿ mfg site), h4.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 mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CARDIOSAVE HYBRID INT TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11382874
• MDR Text Key: 233812063
• Report Number: 2249723-2021-00456
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Device Lot Number: N/A NOT REQUIRED FOR HARDWARE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1