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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 Problems Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Operating System Version or Upgrade Problem (2997)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Parts were discarded.
 
Event Description
It has been reported via a field service report: (b)(4). Symptom: op-on patient. Fos is not working. Findings/action taken: perform functional check - confirmed fiber optic sensor (fos) not working. Found and replaced defective fos print circuit board (pcb) and old fos connector. Fos now - checks ok. Fcn level: 1416. Software level: 2. 24. Per the field service engineer, on tuesday (b)(6) 2017 the pump was not recognizing when a fos balloon was inserted. They just swapped the pump with another one and continued as normal. No patient complications. The field service engineer (fse) replaced a defective fos pcb to repair the problem. The board was one of the old style boards. The fos slider was old so he replaced that as well.
 
Manufacturer Narrative
Teleflex did not receive the device for analysis. The reported complaint of "fos not recognized" was confirmed by the field service engineer. The root cause of the reported complaint is undetermined. A device history record (dhr) review was conducted for the iap serial and lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex will continue to closely monitor.
 
Event Description
It has been reported via a field service report: l612131. Symptom: op-on patient. Fos is not working. Findings/action taken: perform functional check - confirmed fiber optic sensor (fos) not working. Found and replaced defective fos print circuit board (pcb) and old fos connector. Fos now - checks ok. Fcn level: 1416. Software level: 2. 24. Per the field service engineer, on tuesday (b)(6) 2017 the pump was not recognizing when a fos balloon was inserted. They just swapped the pump with another one and continued as normal. No patient complications. The field service engineer (fse) replaced a defective fos pcb to repair the problem. The board was one of the old style boards. The fos slider was old so he replaced that as well.
 
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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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6360866
MDR Text Key68420803
Report Number1219856-2017-00038
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number00801902051714
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 Received03/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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