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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS300 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-XX
Device Problems Loss of Power (1475); Pumping Stopped (1503); Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
On (b)(6)2017, it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification). Further, it was reported the iabp had shutdown/pump stopped. On (b)(6)2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.
 
Manufacturer Narrative
On (b)(6) 2017 06:37 pm (gmt-5:00) added by (b)(6) (b)(4): the production device history record (dhr) for the iabp involved in the event was reviewed. There were no non conformances noted in the dhr related to the reported event. The company field service engineer (fse) evaluated the unit and reviewed the fault logs. The following was reported: the fse was able to confirm the event based on the review of the logs. Further, the pump assembly (part number (b)(4) was replaced and sent to the manufacturer for further evaluation. The pump assembly is still under investigation and the investigation results are pending.
 
Event Description
On (b)(6) 2017, it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification). Further, it was reported the iabp had shutdown/pump stopped. On (b)(6) 2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.
 
Manufacturer Narrative
The replaced part/component, pump assembly (part number 0102-00-0001) was returned to the manufacturing facility for further evaluation. The pump failed testing, the reported failure of "electrical test fails code #50" was verified, and pump does not power up. The company representative disassembled the pump assembly and removed the vacuum and pump heads. The vacuum head internal parts were intact. The internal pressure head parts showed physical damage inside. The retaining screw holding the clamping disc was warped and the clamping disc wore through the head of the retaining screw. Metal filings inside the pump were also observed. The company representative replaced the retaining screw and the clamping disc of the pressure head, reassembled the pump assembly, and tested the pump to factory specifications. Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.
 
Event Description
On (b)(6), it was reported by the customer that while in use on a patient the iabp exhibited error message electrical test fails code #50 (motor speed out of specification). Further, it was reported the iabp had shutdown/pump stopped. On (b)(6) 2017, the customer reported to a maquet representative that the therapy could not be completed and is alleging the patient suffered an adverse event as a result of the iabp malfunction.
 
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Brand NameCS300 INTRA-AORTIC BALLOON PUMP
Type of DeviceSYSTEM, 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 Key6302691
MDR Text Key104296317
Report Number2249723-2017-00005
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-3023-XX
Other Device ID NumberSI190069C1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/03/2017 Patient Sequence Number: 1
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