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

Model Number 0998-UC-3013-55

Device Problem Device Emits Odor (1425)

Patient Problems Headache (1880); Nausea (1970); Pain (1994)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) gave off a sulfur smell.The iabp was not in use at the time of the event when staff detected an unpleasant scratchy smell in the room.Six people were exposed to the smell coming out.In the following hours, the smell intensified and the staff began to report pain headache and nausea.Patients and staff were moved to another part of the medical facility.The fire brigade was called, took measurements, made recommendations and drove away without detecting the source of the smell.The room was intensively aired.Air conditioning and ventilation service were called.It was determined that the iabp was causing the odor.The device was disconnected from electricity and was taken to an emergency room in the basement where there was no staff and patients.It was reported no one suffered from the exposure.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.After inspecting the unit, the fse stated that after the batteries were built, they were found to have the so-called swelling.Slight traces of electrolyte were found in the battery cassette.The batteries had nominal voltages a1: 12.54 v and a2: 12.44 v.The fse then checked the fuses in the power socket and power supply and confirmed that they are ok.Also, small amounts of dust were found inside the pump and at the power supply ventilation inlets, which were cleaned.The pump then started correctly and without errors on ac power.No electrical failures errors were found in the logs.In the service mode, voltage and current were checked with positive result.The batteries were replaced with new ones.After starting and testing, the pump works properly and does not report any error messages.An electrical safety test was performed in accordance with the pn en 62353 standard.The pump was then operational.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL
• 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: 17460166
• MDR Text Key: 320405026
• Report Number: 2249723-2023-03532
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107875
• UDI-Public: 10607567107875
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-UC-3013-55
• Device Catalogue Number: 0998-UC-3013-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention