• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. AEROAUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0535X
Device Problem Device Alarm System (1012)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 04/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported per field service report: symptom - purge failure (5). Findings/action taken: confirmed failure. Could not pull negative (drain valve). Replaced pcs (pneumatic control switch); all works , but has a small helium loss traced to interface block. Replaced interface block. Functional check was performed; pass all. Software level: 2. 24. Additional information stated that the transport team arrived and the patient was on a competitor's intra-aortic balloon pump (iabp). When the team swapped out the pump the arrow pump alarmed purge failure (5). As a result, the patient was put back on the competitor's pump and a second transport team was called. The second teams arrow pump worked fine and the patient was transported to the next facility. There was a reported delay in transport, not in iabp therapy. It is unknown if the delay / interruption was detrimental to the patient's health plan.
 
Manufacturer Narrative
Qn#(b)(4). The pcs assembly (p/n 96-3006-001, s/n (b)(4)) was returned for evaluation. Visual inspection of the pcs assembly was performed and no abnormalities were noted. The pcs assembly in question was installed into a known good autocat2w and performed functional testing. The purge cycle was performed multiple times and passed each time without alarm; however, the pcs assembly failed helium leak test (patient side), the balloon baseline pressure dropped 6 mmhg approximately 15 minutes after the pump was initiated pumping. The known good autocat2w (eng081202w)with the pcs assembly in question installed failed the functional test. The pcs assembly was then removed from the pump. The pcs assembly in question was installed onto the leak tester and failed leak testing. A small leak was noted to be coming from the drain port. Visual inspection of the pcs assembly internal hardware was performed. Rust and dried condensations were found inside the drain valve and manifold block where the drain valve was connected. Notice: the purge failure alarm would occur if system could not pull a negative pressure (drain valve). 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.
 
Event Description
It was reported per field service report: symptom - purge failure (5). Findings/action taken: confirmed failure. Could not pull negative (drain valve). Replaced pcs (pneumatic control switch); all works, but has a small helium loss traced to interface block. Replaced interface block. Functional check was performed; pass all. Software level: 2. 24. Additional information stated that the transport team arrived and the patient was on a competitor's intra-aortic balloon pump (iabp). When the team swapped out the pump the arrow pump alarmed purge failure (5). As a result, the patient was put back on the competitor's pump and a second transport team was called. The second teams arrow pump worked fine and the patient was transported to the next facility. There was a reported delay in transport, not in iabp therapy. It is unknown if the delay / interruption was detrimental to the patient's health plan.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAEROAUTOCAT 2 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 Key5660541
MDR Text Key45326725
Report Number1219856-2016-00117
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0535X
Device Lot Number40540W
Other Device ID Number30801902051739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-