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 Problems Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191); Unexpected Shutdown (4019)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device(10,3213) a getinge field service engineer (fse) was dispatched to evaluate this unit.Customer stated the system would display a communication error and shut down.Fse observed system and entered log for insight to troubleshooting.Error log indicated drive transducer failure.Fse replaced drive transducer.During testing system would not pass 30 psi calibration.Fse troubleshooted system and determined the pim assembly was defective.Fse returned with pim module and replaced assembly.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.A supplemental report will be submitted upon completion of our investigation the full name of the event site was shortened due to field character limit; the full name is (b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had communication error 21.It is unknown under which circumstances this event occurred; however there was no patient involvement, and no adverse event was reported.Communication error 21.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (type of investigation), (investigation findings), (investigation conclusions), h10, h11.Corrected fields: a1, b5, b6, b7, d5, d10, h6 (device code), (component codes), (health effects- impact codes).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 24 month product complaint trend data for the period oct 2019 through sep 2021 was reviewed.There were no triggers identified for the review period.

Event Description

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) had communication error 21 and shut down which were related issues.There was no patient harm or injury and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d10, g4, g7, h2, h10, h11.Corrected fields: d11, g1(contact person).The pressure transducer w/ 4"cbl and pneumatic module assy, rohs were both returned to getinge's national repair center(nrc) for evaluation.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h6(investigation type), h10, h11.Corrected fields: g1(contact person), h6(clinical code, problem code, component codes & impact codes), the patient interface module and 30 psi transducer was returned to failure analysis and testing for evaluation.The failure analysis and testing department (fat) received the patient interface module and 30 psi transducer.The failure analysis and testing department installed the patient interface module into the cardiosave test fixture and tested the patient interface module to factory specifications per procedure and the cardiosave service manual.The fat dept.Verified the failure of the patient interface module failure -unable to perform 30 psi calibration.During the evaluation it was observed that fluid ingress believed to be saline was observed on exit side of k10 valve and the input side of the safety disk.Retaining the patient interface module in the fat dept.Per procedure.The failure analysis and testing department installed the 30 psi transducer into the cardiosave test fixture and tested the 30 psi transducer to factory specifications per procedure and the cardiosave service manual.The fat dept.Could not verified the failure of the error code 124 - 30 psi transducer out of calibration with just the 30 psi transducer installed, as stated in the initial complaint -"error code 124 - 30 psi transducer out of calibration".Retaining the 30 psi transducer in the fat dept.Per procedure.Note: when tested as a group of 30 psi transducer and pim together the failure of unable to calibrate 30 psi transducer was observed.However no 124 failure code were observed.

• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12651471
• MDR Text Key: 281342179
• Report Number: 2249723-2021-02378
• 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,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON CATHETER.; N/A.; UNKNOWN.