MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-3013-53

Device Problems Loss of Power (1475); Device Inoperable (1663)

Patient Problem Death (1802)

Event Date 05/31/2017

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.On 18-july-2017, the customer biomed reported that the iabp unit has been quarantined in the office since the event.They tried exchanging the safety disk and balloon catheter with known good ones but the issue persisted.Repairs will be made at the discretion of the department.If additional information is provided, we will report the information accordingly.

Event Description

A company representative reported that they were at (b)(6) hospital on (b)(6) 2017, and a comment was made to them in the cath lab that the operating room (or) had used a cs100 intra-aortic balloon pump (iabp) on a patient and the pump malfunctioned and stopped working.The company representative's calls to the biomed were not returned.The pump is a cs100 and maquet/getinge did not work on this pump.The customer has a service contract with ge biomed group.The company representative was unable to locate the pump at the hospital.The company rep reached out to the perfusionist who told them that the pump was taken to the biomed and he was told that there was something wrong with the disk.The company rep did update their service territory manager (stm).(b)(6) hospital was fully aware of the end of service of cs100s by maquet/getinge on 31-dec-2015.The company rep was unable to get any facts pertaining to the patient except that the patient was "very sick".The customer never notified the company rep or their service tm of this incident.No adverse event was reported at the time of the initial report.It was later reported on 18-july-2017 that the patient subsequently died.An email has been sent to the customer to obtain additional information.

Manufacturer Narrative

(b)(4).On(b)(6) 2017, the customer's biomed reported that she was told that the patient did pass away while in the hospital; however it was not due to the procedure or incident.The patient passed away due to pre- existing conditions - no additional patient information was provided.A maquet balloon was used during the procedure.The unit was not repaired and was retired from use.The customer's biomed has confirmed that the patient's death that occurred was not attributed to the iabp device or iabp therapy.The iabp unit has been taken out of service due to end of life problem.

Event Description

A company representative reported that they were at (b)(6) hospital on (b)(6) 2017, and a comment was made to them in the cath lab that the operating room (or) had used a cs100 intra-aortic balloon pump (iabp) on a patient and the pump malfunctioned and stopped working.The company representative's calls to the biomed were not returned.The pump is a cs100 and maquet/getinge did not work on this pump.The customer has a service contract with ge biomed group.The company representative was unable to locate the pump at the hospital.The company rep reached out to the perfusionist who told them that the pump was taken to the biomed and he was told that there was something wrong with the disk.The company rep did update their service territory manager (stm).(b)(6)hospital was fully aware of the end of service of cs100s by maquet/getinge on (b)(6) 2015.The company rep was unable to get any facts pertaining to the patient except that the patient was "very sick".The customer never notified the company rep or their service tm of this incident.No adverse event was reported at the time of the initial report.It was later reported on (b)(6) 2017 that the patient subsequently died.An email has been sent to the customer to obtain additional information.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6792267
• MDR Text Key: 82618494
• Report Number: 2249723-2017-00274
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 09/11/2017
• Date Device Manufactured: 06/16/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 66