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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems No Audible Alarm (1019); Fluid/Blood Leak (1250); Material Rupture (1546); Device Contamination with Body Fluid (2317)
Patient Problems Chest Pain (1776); No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2018
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to investigate.The stm performed a non-invasive performance tests but did not change any settings.The stm was able to duplicate the reported error using his iabp trainer and a test catheter.The stm reviewed the error logs for the date of the incident and "check catheter" was displayed 5 times; however, no blood back alarms were reported on the date of incident because the blood seen by the operator in the iab catheter never reached the iabp.The stm was able to verify that blood back detection circuit works properly and alarms accordingly using the blood back test chapter of the service manual.The error/fault logs reflected the blood back faults that the stm generated but no other faults reported.The stm also noted that the iabp unit was due for preventative maintenance (pm) in september.Pms and service are performed by the in-house biomed shop.The iabp unit passed all functional tests.The stm believes that the unit is working within normal parameters and functioned properly during the balloon rupture in the patient during the procedure.Unrelated to the event, the stm noted that the unit was dirty and showed signs of saline intrusion and is going to require the 5000 hour kit.The biomed has been informed and noted this.The customer safety officer stated that they will be keeping the unit out of service in sequester until their investigation is completed.A supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) alarmed "check iab catheter".The staff noted blood in the gas line.The intra-aortic balloon (iab) was removed, as it was reported to have ruptured.The iabp was pulled out of service and sent to the safety officer because the iabp did not alarm ¿blood detected¿.There was no patient injury or adverse event reported.
 
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-conformance's in the production dhr related to the reported event.The getinge stm reported that the customer still has the iabp unit sequestered and has not cleared the unit for clinical use.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) alarmed "check iab catheter".The staff noted blood in the gas line.The intra-aortic balloon (iab) was removed, as it was reported to have ruptured.The iabp was pulled out of service and sent to the safety officer because the iabp did not alarm ¿blood detected¿.The following event was received via medwatch ((b)(6)) from an unknown reporter on (b)(6)2018.It was reported that the patient underwent subclavian placement of an intra-aortic balloon (iab).The following day, the intra-aortic balloon pump (iabp) alarmed ¿check in iab catheter" occasionally when the patient was sitting with head down slumping.The iabp then stopped alarming when the patient was sitting up straight.When getting back to bed, the patient complained of pain in chest with movement, but the pain went away once straightened out.The nurse noticed blood in the iab catheter tubing.The patient was emergently taken to the craterization lab for replacement of the iab catheter.The iab catheter was found to have ruptured.A new iabp console was used.
 
Manufacturer Narrative
Corrected field: device code.A getinge field service engineer (fse) reported that he was informed that the involved cs300 was released from sequester at some point earlier this year, following the customer¿s internal investigation.Information on the final result of their investigation was not provided.The getinge fse confirmed that subsequent to the reported event, he had performed a preventative maintenance on the iabp and has cleared it for clinical use.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) alarmed "check iab catheter".The staff noted blood in the gas line.The intra-aortic balloon (iab) was removed, as it was reported to have ruptured.The iabp was pulled out of service and sent to the safety officer because the iabp did not alarm ¿blood detected¿.The following event was received via medwatch (mw5079337) from an unknown reporter on 06-sep-2018.It was reported that the patient underwent subclavian placement of an intra-aortic balloon (iab).The following day, the intra-aortic balloon pump (iabp) alarmed ¿check in iab catheter" occasionally when the patient was sitting with head down slumping.The iabp then stopped alarming when the patient was sitting up straight.When getting back to bed, the patient complained of pain in chest with movement, but the pain went away once straightened out.The nurse noticed blood in the iab catheter tubing.The patient was emergently taken to the catherization lab for replacement of the iab catheter.The iab catheter was found to have ruptured.A new iabp console was used.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key7863836
MDR Text Key120119825
Report Number2249723-2018-01562
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Device Age YR
Initial Date Manufacturer Received 08/17/2018
Initial Date FDA Received09/11/2018
Supplement Dates Manufacturer Received09/06/2018
05/08/2019
Supplement Dates FDA Received09/28/2018
05/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient Weight88
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