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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 Problems Unable to Obtain Readings (1516); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It was reported by the rn and the medical doctor that the iab and iabp were not the cause of the patient's death. It was stated in the reported complaint that the catheter was discarded and therefore not returned to (b)(4) to be investigated. Other remarks: see mdr# 1219856-2016-00283/1900049680 for other report.
 
Event Description
It has been reported via a hot line call. The registered nurse (rn) stated that after removing the first intra-aortic balloon (iab) they inserted a second intra-aortic balloon (iab) and are having the "same problem" with this pump (s/n (b)(4)). The registered nurse (rn) stated that the fiber optic arterial line (a-line) "would not zero. " the patient currently critical. Immediate assessment revealed that although the fiber optic sensor (fos) slide and cal key were connected, there were no waveforms present and no other connections made to the pump. The clinical support specialist explained that we needed to establish a trigger. The rn was focused on the fiber optic sensor (fos). The clinical support specialist (css) explained that we would work on that after, right now it is most important to establish a trigger for the pump to use. Per the rn, they had not yet connected the transducer to the pump and during the delay trying to transduce the central lumen, the css directed the rn to put leads on the patient where ever she could place them. Once the leads were on and electrocardiogram (ecg) was established, red blinking heart and trigger recognition verified, the css directed the rn to press pump on. The pump immediately began pumping utilizing the ecg trigger and weissler timing. The css then worked with the rn to verify central lumen transduced to the pump, and waveform was now present. The css asked the rn to disconnect and reconnect the fiber optic sensor (fos) slide and cal key at which time she reported that she had tried that several times. The css asked the rn to repeat this and explained the indicators that we are looking for to verify the connection. At this time the fos slide is "stuck" in the pump and cannot be removed. The css told the rn to proceed with the pump as currently set. Goals of therapy being met. Patient in sinus tachycardia (tach) 120's, pump now returned to 1:1, pumping without alarms. The css asked the rn to call back after they complete the case so that the css can get more information and discuss the possible problems they had with the fos connection and if they have any additional problems in the meantime, call me immediately. @ 1351- the rn called back to provide the css with the serial numbers. The css discussed the fos connection with the rn, it seems that they never established connection with either catheter (no audible tones) the second catheter inserted was s/n (b)(4). The css also discussed in length with the rn the potential causes for the connector not to make the connection. The css also discussed that the zero is separate and not necessary to initiate pumping. The css then reviewed triggers and trigger assessment with the rn. The css also spoke to the scrub for the case. The scrub reported that the stylet was removed after the catheter was removed from the tray, but that the catheter was out of the tray prior to connection to the pump. The css reviewed catheter prep and potential damage to the connector and or fiber. The css reviewed with the rn and the scrub that the central lumen can always serve as a backup and the pump would automatically select it if it had been connected to the pump. The rn and scrub reported that the patient expired, "a while" after our call and both the rn and the scrub report that the intra-aortic balloon (iab), intra-aortic balloon pump (iabp)and delay in therapy were not the cause of the patient's death. The scrub reported that "there was nothing that could have changed the outcome. " outcome of patient: patient supported on pump, but later expired.
 
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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
carmen sherman
3015 carrington mill blvd
morrisville 27560
MDR Report Key6220190
MDR Text Key63805832
Report Number1219856-2016-00282
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
Report Date 12/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAB-05840-LWS
Other Device ID Number00801902007247
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 Received12/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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