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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-65
Device Problems Backflow (1064); Restricted Flow rate (1248); Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that after one day of intra-aortic balloon (iab) therapy, the cs100 intra-aortic balloon pump (iabp) frequently generated a check iab catheter alarm.The drive tube outside the body was checked, but there was no blood seen.Since the alarm occurred again the next day, the iabp was switched to a cs300.Blood was then seen in the tubing and entered the iabp.Therapy was completed so the iab was removed.There was no patient harm or adverse event reported.Related to balloon complaint tw (b)(4).
 
Event Description
N/a.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate the issue.The fse stated that the alarm was caused by the damage of the concomitant iab catheter and not the unit itself.Also due to the damaged concomitant iab catheter, blood was entered into the console of the unit.In order to solve the issue, the fse replaced the following parts: safety disk, condensate removal module (crm), purge valve assembly, and blood detect tubing.The fse then stated that the repair was completed.
 
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Brand Name
CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
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 Key16777655
MDR Text Key314040444
Report Number2249723-2023-02016
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107684
UDI-Public10607567107684
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3013-65
Device Catalogue Number0998-00-3013-65
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/28/2023
Initial Date FDA Received04/20/2023
Supplement Dates Manufacturer Received08/12/2023
Supplement Dates FDA Received08/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2009
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
TRANSRAY 34CC BALLOON.
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