MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN INTRA-AORTIC BALLOON PUMP (IABP); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number UNKNOWN

Device Problem Inability to Auto-Fill (1044)

Patient Problem Ischemia (1942)

Event Date 05/22/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.Attempts are being made to obtain additional information, and a supplemental report will be submitted if additional information is provided.The full name of the event site was shortened due to field character limit; the full name is (b)(6).Not returned to manufacturer.

Event Description

It was reported that the intra-aortic balloon pump (iabp) generated an autofill failure and would not inflate causing ischemia to the patient.It was later reported that the ischemia in the patient's leg was related to his general condition.At this time, the customer has not attributed the event to the iabp unit involved.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h4, h6, h10.Analysis of production: (3331) the device history record (dhr) for this iabp unit cannot be reviewed since the serial number for the unit was not provided.Historical data analysis: (4109) no complaint history review can be performed as the serial of the iabp is unknown.Trend analysis: (4110) trend analysis cannot be performed as the model of the iabp is unknown.

Event Description

N/a.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON PUMP (IABP)
• 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: 12035767
• MDR Text Key: 257398189
• Report Number: 2249723-2021-01317
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MEGA 50CC IAB CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male