MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-45

Device Problem Device Contamination with Body Fluid (2317)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use, the cs100 intra-aortic balloon pump (iabp) units balloon was damaged causing blood to enter the device.The customer stopped using the device promptly.There was no patient injury reported.

Manufacturer Narrative

This complaint is being closed as it was opened in error.Revert all sections to blank : b.Adverse event or product problem d.Suspect medical device e.Initial reporter g.All manufacturers h.Device manufacturers only.

Event Description

This complaint is being cancelled as it was opened in error.

Event Description

It was reported that during use, the cs100 intra-aortic balloon pump (iabp) units balloon was damaged causing blood to enter the device.The customer stopped using the device promptly.Additional information received later confirmed that it was the facilities belief that blood had entered the iabp.There was no patient injury reported.

Manufacturer Narrative

Disregard prior statement in follow up # 1.

Manufacturer Narrative

Corrected data: d10.Updated data: b4, g3, g6, h2, h10, h11.

Event Description

N/a.

Manufacturer Narrative

Due to character restriction e1 is (b)(6).A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the balloon was damaged, and caused blood to enter the combination valve.The fse replaced the blood detect tubing, condensate removal module, safety disk and purge valve assembly and unit passed all functional and safety tests, and was returned to customer.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
• 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: 18120326
• MDR Text Key: 327936414
• Report Number: 2249723-2023-04827
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: 10607567107790
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ARROW BALLOON.; UNKNOWN.
• Patient Sex: Prefer Not To Disclose