MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-58

Device Problem Inability to Auto-Fill (1044)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had an autofill failure.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

It cannot be confirmed if the repair information that was provided is new information related to the supported investigation of this event.This is a preliminary follow up report.The information provided by the ssu is not considered new information supporting the investigation of the event for tw# (b)(4).No information was provided indicating that after the repair of broken connector the iabp device was cleared to clinical use.Preliminary follow up is submitted to the fda to provide available information; however, it is still being verified if the information provided is a new information to support this event investigation.A supplemental will be submitted as soon as valid information pertaining to autofill reported event is provided.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had an autofill failure.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported that during start up verification, the cs300 intra- aortic balloon pump (iabp) had an autofill failure.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: a1, b4, b5, b6, b7, d4(model#), d11, e1(event site email), g4, g7, h2, h3, h6(investigation type, investigation findings, investigation conclusions, impact codes & component codes), h7, h10, h11.Corrected fields: d1, d4(catalog# &udi#), g1(contact person), h4.A getinge field service engineer (fse) was dispatched to evaluate the iabp and verified leak at the fill connector.The fse replaced the broken purge connector and unit no longer leaked.Mandatory service and checklist protocols were passed and the machine cleared for clinical use.Analysis of production: (3331/102) 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: (4109/102) 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: (4110/102) 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.

Manufacturer Narrative

The aware date reported in the initial report was submitted incorrectly.The aware date should read: 02jan2021.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V
• 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: 11208661
• MDR Text Key: 228862657
• Report Number: 2249723-2021-00129
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108339
• UDI-Public: 10607567108339
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K063525
• 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,Followup
• Report Date: 04/29/2022

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: 0998-00-3023-58
• Device Catalogue Number: 0998-00-3023-58
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 03/17/2021; 03/30/2022; 04/13/2022
• Supplement Dates FDA Received: 03/24/2021; 04/26/2022; 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2010
• 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