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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 Display or Visual Feedback Problem (1184)
Patient Problem Insufficiency, Valvular (1926)
Event Date 09/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). See mdr #1219856-2016-00230.
 
Event Description
It was been reported that while in the operating room or during bypass surgery the console "screen was pixelated" the pump was still pumping and did not alarm however , the perfusionist wanted to switch it out. The pump was exchanged without issue. The pump was taken to biomed, and the biomed tech contacted the field service agent. The fsa arrived at the facility on (b)(6) 2016. The perfusionist said that the "display was pixelated although he thought the pump was still pumping fine. " the patient did expire however per the perfusionist and the md the death is not attributed to the pixelated display on the console. Additional information received on (b)(6) 2016 from the field service report: (b)(6) symptom: display problem symptom/action taken: perform functional check - found intermittent with green pixels after warm-up; replace display (also display wiggles after hot) fcn level: 1416, less than 12 months, software level: 2. 24.
 
Manufacturer Narrative
(b)(4). See mdr #1219856-2016-00230. The display head assembly (p/n 77-3016-001w, s/n (b)(4)) was returned for evaluation. Visual inspection of the display head assembly was performed and no damages or defects were noted. The display head assembly was installed onto the known good autocat2w and functional evaluation was performed. A green spot was found on the display screen over the ecg waveform. The green spot was determined to be energized pixel. The energized pixel (green) was in the fixed position and not affects to the waveform presented. Every button on the display head assembly were pressed multiple times (wait for 10 seconds on each press) when the pump was powered; and no alarms or errors were occurred. Also, shook the display head while the pump was pumping with no alarms or distortion observed. The pump was then left to run for over six hours with no pixilation issue or errors. The display head in question passed functional testing. Per procedure four (4) spots/pits with spot size 0. 020" or less are acceptable in the manufacturing process. Visual inspection of the display head assembly internal hardware was performed and found no loose connections or loose hardware. All connectors were proper seated. See other remarks section. Other remarks: 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 "pixelate on the display" was confirmed by the field service engineer; however, the pixilation on the display could not be replicated at the (b)(4) facility during the functional test. The cause of the reported complaint is undetermined.
 
Event Description
It was been reported that while in the operating room (or) during bypass surgery the console "screen was pixelated" the pump was still pumping and did not alarm however , the perfusionist wanted to switch it out. The pump was exchanged without issue. The pump was taken to biomed, and the biomed tech contacted the field service agent. The fsa arrived at the facility on 16sept2016. The perfusionist said that the "display was pixelated although he thought the pump was still pumping fine. " the patient did expire however per the perfusionist and the md the death is not attributed to the pixelated display on the console. Additional information received on 09/20/2016 from the field service report: (b)(4). Symptom: display problem. Symptom/action taken: perform functional check - found intermittent with green pixels after warm-up - replace display (also display wiggles after hot). Fcn level: 1416, < 12 months, software level: 2. 24.
 
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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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6022863
MDR Text Key57307621
Report Number1219856-2016-00219
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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