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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problem Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No components were returned to date.
 
Event Description
It was reported via a hot line call. The registered nurse (rn) is calling to report a possible helium loss alarm (2 in the operating rom and 1 in intensive care unit). They have since changed the pump out for a second pump ((b)(4)). No blood is present in the driveline and the pump has not alarmed since switching to the second one. The rn and clinical support specialist (css)c discussed that there could be a small hole in the membrane and they need to be very diligent in checking the tubing over time and with any subsequent alarms. The rn verbalized understanding and the css discussed some other possible causes for the alarm, one of which is a leak internally in the first pump. The css suggested that the first pump ((b)(4)) be sent to biomed to be checked for any leaks internally. The css received no future calls.
 
Manufacturer Narrative
(b)(4). No iabp parts or recorder strips were returned to teleflex (b)(4) for evaluation. It has been reported that the pump alarmed "helium loss alarms". This alarm indicates that there may be a leak in tubing and connections, blood in catheter, kinked catheter, or ectopic beats. After the css discussed the possible causes for the alarm, the css suggested sending the pump to biomed to be checked out. Additional follow up information received from the hospital biomed stated that the pump was not sent to the biomed department. The biomed had nothing in his database related to the call report. The (wws) world wide support database was also checked and there was no further service provided to the pump related to the reported call report. Device history record (dhr) review was conducted for the iap serial and lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint of "helium leak alarm" is not confirmed. The pump was not sent to the biomed department. The wws database was also checked and there was no further service provided to the pump related to the reported call report. The cause of reported complaint is undetermined.
 
Event Description
It was reported via a hot line call. The registered nurse (rn) is calling to report a possible helium loss alarm (2 in the operating rom and 1 in intensive care unit). They have since changed the pump out for a second pump (s/n (b)(4). No blood is present in the driveline and the pump has not alarmed since switching to the second one. The rn and clinical support specialist (css)c discussed that there could be a small hole in the membrane and they need to be very diligent in checking the tubing over time and with any subsequent alarms. The rn verbalized understanding and the css discussed some other possible causes for the alarm, one of which is a leak internally in the first pump. The css suggested that the first pump (s/n (b)(4) be sent to biomed to be checked for any leaks internally. The css received no future calls.
 
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Brand NameAUTOCAT2 WAVE
Type of DeviceINTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6071451
MDR Text Key58937685
Report Number1219856-2016-00235
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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