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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 Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hot line call. The registered nurse (rn) from the intensive care unit (icu) has a patient from the cath lab with a 40 cc intra-aortic balloon (iab) in place in the right femoral artery. In a sinus tachycardia and with dobutamine infusing. The patient has only been in the unit about 15 minutes. They have been getting frequent high baseline alarms. They have checked to make sure there are no kinks on the line, the helium tank is open. The intra-aortic balloon (iab) position was checked. The clinical support specialist (css) explained that the main cause for high baseline alarms was a kink to the catheter. The clinical support specialist (css) had them try placing some traction on the line and hyperextending the hip. The pump would pump longer, but they still would get the high baseline alarm. The clinical support specialist (css) had them try decreasing the volume to 35 cc. They still got the high baseline alarms. The patient has a large pannus and they are trying to get that lifted off the groin site. The clinical support specialist (css) had the registered nurse (rn) next try placing the patient on their side with the balloon leg on the upside. They still are getting high baseline and also possible helium loss alarms. There is no blood in the line. The clinical support specialist (css) and registered nurse (rn) did an internal leak test with the balloon and the balloon is good, but the baseline on the balloon pressure waveform (bpw) is below zero. The clinical support specialist (css) had them power the pump off and then back on. The balloon pressure waveform (bpw) continues to be below the baseline. The clinical support specialist (css) then recommended that they try changing the pump out. When the clinical support specialist (css) called back, the registered nurse (rn) told me that the physician had come in the decided just to discontinue the intra-aortic balloon (iab). The patient was stable without the intra-aortic balloon (iab).
 
Manufacturer Narrative
(b)(4). A full evaluation was not performed as no device or parts were returned to teleflex. 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. The reported complaint of "alarm, high baseline" is confirmed based off the information provided to the clinical support specialist. The iabp was checked and repaired by the hospital biomed and has been returned to service. No iap parts or recorder strips were returned for evaluation at the teleflex (b)(4) facility therefore, the cause of the reported complaint could not be determined. Teleflex will continue to monitor for any trending issues.
 
Event Description
It was reported via a hot line call. The registered nurse (rn) from the intensive care unit (icu) has a patient from the cath lab with a 40 cc intra-aortic balloon (iab) in place in the right femoral artery. In a sinus tachycardia and with dobutamine infusing. The patient has only been in the unit about 15 minutes. They have been getting frequent high baseline alarms. They have checked to make sure there are no kinks on the line, the helium tank is open. The intra-aortic balloon (iab) position was checked. The clinical support specialist (css) explained that the main cause for high baseline alarms was a kink to the catheter. The clinical support specialist (css) had them try placing some traction on the line and hyperextending the hip. The pump would pump longer, but they still would get the high baseline alarm. The clinical support specialist (css) had them try decreasing the volume to 35 cc. They still got the high baseline alarms. The patient has a large pannus and they are trying to get that lifted off the groin site. The clinical support specialist (css) had the registered nurse (rn) next try placing the patient on their side with the balloon leg on the upside. They still are getting high baseline and also possible helium loss alarms. There is no blood in the line. The clinical support specialist (css) and registered nurse (rn) did an internal leak test with the balloon and the balloon is good, but the baseline on the balloon pressure waveform (bpw) is below zero. The clinical support specialist (css) had them power the pump off and then back on. The balloon pressure waveform (bpw) continues to be below the baseline. The clinical support specialist (css) then recommended that they try changing the pump out. When the clinical support specialist (css) called back, the registered nurse (rn) told me that the physician had come in the decided just to discontinue the intra-aortic balloon (iab). The patient was stable without the intra-aortic balloon (iab).
 
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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
carmen sherman
3015 carrington mill blvd
morrisville 27560
MDR Report Key6173164
MDR Text Key62329459
Report Number1219856-2016-00284
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 12/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number00801902051714
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 Received01/18/2017
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 Reuse

Patient Treatment Data
Date Received: 12/14/2016 Patient Sequence Number: 1
Treatment
DOBUTAMINE DRIP
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