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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500
Device Problems Device Alarm System (1012); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) while in use, the staff experienced a system error #3 alarm and a high baseline alarm.As a result, the pump was switched out quickly.The pump was sent to biomed.The biomedical engineer found that the pins on the mforce motor driver were charred.The biomed replaced the driver.It was also noted by the staff that the pump would give "running on battery alarm" when the pump was jostled.The pump was sent to biomed, where the power supply was replaced.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of system error 3 alarm is confirmed.The pump alarmed system error 3 during the functional test with the returned motor driver cable installed.Upon return, discoloration consistent with burn marks was noted on the connector and on the motor driver cable.The root cause of motor driver cable failure is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.A nonconformance has been initiated to further investigate the root cause.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) while in use, the staff experienced a system error #3 alarm and a high baseline alarm.As a result, the pump was switched out quickly.The pump was sent to biomed.The biomedical engineer found that the pins on the mforce motor driver were charred.The biomed replaced the driver.It was also noted by the staff that the pump would give "running on battery alarm" when the pump was jostled.The pump was sent to biomed, where the power supply was replaced.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
 
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Brand Name
AUTOCAT2 WAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8299662
MDR Text Key134859845
Report Number3010532612-2019-00010
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902051714
UDI-Public00801902051714
Combination Product (y/n)N
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Date Manufacturer Received02/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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