MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-UC-3013-53

Device Problem Gas/Air Leak (2946)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse observed helium leakage noise at the helium cylinder connecting point and found the washer was damaged.The fse replaced the washer with another then checked for helium leakage nd found no further leakage.The fse checked the iabp performance on a trainer and intra-aortic balloon (iab).The iabp functioned satisfactorily.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) had a helium leak.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

The unit was returned to the customer and cleared for clinical use.

Event Description

It was reported that during a routine check, the cs100 intra-aortic balloon pump (iabp) had a helium leak.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

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 12 month product complaint trend data for the period (b)(6) 2020 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11338091
• MDR Text Key: 232222888
• Report Number: 2249723-2021-00311
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107745
• UDI-Public: 10607567107745
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2021

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: 0998-UC-3013-53
• Device Catalogue Number: 0998-UC-3013-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/11/2021; 10/26/2021
• Supplement Dates FDA Received: 03/31/2021; 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.