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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Fluid Leak (1250)
Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Ischemic Heart Disease (2493)
Event Date 09/07/2016
Event Type  malfunction  
Manufacturer Narrative
Concomitant products: ine drips. (b)(4).
 
Event Description
It was reported via a hotline call from the registered nurse (rn) in the cardiac icu calling for another rn who is taking care of the patient. The iab was inserted in the lab via right femoral access. The patient had no alarms, is not moving, no visible kinking prior to event. The physician's assistant is at bedside to pull the iab and wanted the rn to call the hotline. The rn relayed that at 0405 the pump alarmed high pressure and upon inspection of the driveline, saw blood in the line about 10' into the tubing. The pump has been off since then. The pa then came on the phone and discussed the concern of the clotted blood in the driveline getting into the patient when she removed the iab. The clinical support specialist explained that the blood from the driveline tubing would not get into the patient, but if the iab remained in the patient over 30 minutes since pumping ceased, there could be a thrombus formation on the membrane or difficulty removing the iab if the blood in the membrane became too hard/dried. The pa has no further questions and is going to pull the iab now and save for return. The rn came back on the phone and said the patient has remained stable with the pump off and there is no discussion of placing a second iab. Iabp was on 1:1 assist prior to event.
 
Manufacturer Narrative
Concomitant medical products: ine drips. (b)(4) no product was returned for evaluation. 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. Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined. If the sample is returned at a later date, a full investigation will be completed.
 
Event Description
It was reported via a hotline call from the registered nurse (rn) in the cardiac icu calling for another rn who is taking care of the patient. The iab was inserted in the lab via right femoral access. The patient had no alarms, is not moving, no visible kinking prior to event. The physician's assistant is at bedside to pull the iab and wanted the rn to call the hotline. The rn relayed that at 0405 the pump alarmed high pressure and upon inspection of the driveline, saw blood in the line about 10' into the tubing. The pump has been off since then. The pa then came on the phone and discussed the concern of the clotted blood in the driveline getting into the patient when she removed the iab. The clinical support specialist explained that the blood from the driveline tubing would not get into the patient, but if the iab remained in the patient over 30 minutes since pumping ceased, there could be a thrombus formation on the membrane or difficulty removing the iab if the blood in the membrane became too hard/dried. The pa has no further questions and is going to pull the iab now and save for return. The rn came back on the phone and said the patient has remained stable with the pump off and there is no discussion of placing a second iab. Iabp was on 1:1 assist prior to event.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- AORTIC BALLOON FIBER OPTIC
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 Key5994764
MDR Text Key56359400
Report Number1219856-2016-00233
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
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 09/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18S15A0026
Other Device ID Number00801902007247
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/03/2016 Patient Sequence Number: 1
Treatment
SUPPORTED HEMODYNAMICALLY ON LEVOPHED AND EPINEPHR
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