MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/30/2020

Event Type  Death  

Manufacturer Narrative

Additional initial reporter name - (b)(6).Additional email address - (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) shutdown in the middle of the therapy.In addition customer reported that no alarms were heard and no abnormal operation was detected.The customer then turned the power switch off and back on and the unit was able to turned on, the patient therapy was discontinued and patient was transitioned to another cs300 iabp.There was no reported malfunction on the intra-aortic balloon(iab).A separate report will be submitted for the cs300 intra-aortic balloon pump (iabp).

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Failure modes are addressed in the risk file.The ifu cannot be reviewed as there was no reported malfunction.There were no ncmrs identified.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #: (b)(4).

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) shutdown in the middle of the therapy.In addition customer reported that no alarms were heard and no abnormal operation was detected.The customer then turned the power switch off and back on and the unit was able to turned on, the patient therapy was discontinued and patient was transitioned to another cs300 iabp.There was no reported malfunction on the intra-aortic balloon(iab).A separate report will be submitted for the cs300 intra-aortic balloon pump (iabp).

• Brand Name: UNKNOWN IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: dorota wolpiuk ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 10945264
• MDR Text Key: 219483834
• Report Number: 2248146-2020-00642
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CS300
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Weight: 71