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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 Deformation Due to Compressive Stress (2889); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the rn that they have a patient on the intra-aortic balloon pump (iabp) and the pump had a low helium tank alarm and they changed out the helium tank. Then the pump alarmed again, and the pump stopped pumping. The rn reported unable to refill, high baseline and possible helium loss. There is no signs of blood in the tubing. The patient is a fairly large patient so they had to put traction on the catheter and hyperextend the hip. The pump pumped for several minutes and then it alarmed again. As a result, the pump was switched out for a second pump without consequence. There was no report of delay in therapy. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iabp multiple alarms: "unable to refill", "high baseline", and "possible helium loss" is not able to be confirmed. An elevated baseline was noted on the recorder strip and pump display photos submitted with the complaint, however, no alarms were noted on the photos provided. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported by the rn that they have a patient on the intra-aortic balloon pump (iabp) and the pump had a low helium tank alarm and they changed out the helium tank. Then the pump alarmed again, and the pump stopped pumping. The rn reported unable to refill, high baseline and possible helium loss. There is no signs of blood in the tubing. The patient is a fairly large patient so they had to put traction on the catheter and hyperextend the hip. The pump pumped for several minutes and then it alarmed again. As a result, the pump was switched out for a second pump without consequence. There was no report of delay in therapy. There was no report of patient complications, serious injury or death.
 
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Brand NameAUTOCAT2 WAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8780414
MDR Text Key150698972
Report Number3010532612-2019-00213
Device Sequence Number1
Product Code DSP
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 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/11/2019 Patient Sequence Number: 1
Treatment
DOBUMATAMINEAMIODARONE; DOBUMATAMINEAMIODARONE; DOBUMATAMINEAMIODARONE
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