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

Model Number 0998-00-0800-52

Device Problem Device Alarm System (1012)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to verify the alarm in the error logs.Unit passed all functional and safety test per factory specifications.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) gave catheter restriction alarm.Patient was stable and customer swapped to another unit.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to verify the alarm in the error logs.The fse inspected the iabp unit and performed a full calibration including functional checks but no fault was observed.Subsequently, the fse completed all functional and safety test per factory specifications and all testing passed.The iabp unit was then cleared for use and returned to the customer.

Event Description

N/a.

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 jun-2019 through may-2021 was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE G 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: 11966944
• MDR Text Key: 259717196
• Report Number: 2249723-2021-01225
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2022

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: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 06/10/2021; 04/15/2022
• Supplement Dates FDA Received: 07/02/2021; 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose