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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL

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ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problem Occlusion Within Device (1423)
Patient Problem Venipuncture (2129)
Event Date 09/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of poor ap waveform signal is confirmed based on the picture sent with the complaint report. According to the event details, the iab was used with an alternative source for pressure measurement. The root cause of the reported complaint is undetermined. The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings. All devices passed manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the event occurred during use. The rn called the clinical support specialist (css) and stated they had a patient on the pump and they could not get an arterial pressure (ap) waveform to appear on the screen. The rn stated that as they repositioned the catheter and advanced it, the ap waveform disappeared. When they pulled the catheter back about a centimeter they were not able to flush the catheter. The css told the rn the catheter is most likely clotted and suggested they use an alternate arterial line. Additional information received by the intensive care unit educator: the central lumen occluded but the patient continued to cardiac arrest and was not stable to change the intra-aortic balloon (iab). The patient went to the cardiac cath lab and received four drug eluting stents as well as an arterial line. Patient outcome: reported as stable. There was no reported patient death or complications.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the event occurred during use. The rn called the clinical support specialist (css) and stated they had a patient on the pump and they could not get an arterial pressure (ap) waveform to appear on the screen. The rn stated that as they repositioned the catheter and advanced it, the ap waveform disappeared. When they pulled the catheter back about a centimeter they were not able to flush the catheter. The css told the rn the catheter is most likely clotted and suggested they use an alternate arterial line. Additional information received by the intensive care unit educator: the central lumen occluded but the patient continued to cardiac arrest and was not stable to change the intra-aortic balloon (iab). The patient went to the cardiac cath lab and received four drug eluting stents as well as an arterial line. Patient outcome: reported as stable. There was no reported patient death or complications.
 
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Brand NameCARDIAC UNKNOWN DUMMY MATERIAL
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6930681
MDR Text Key247686762
Report Number1219856-2017-00226
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberN/A
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 Received11/09/2017
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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