MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE FRENCH; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0500F

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a field service report: 061016m.Symptom: helium leak.Findings / action taken: pcs assembly replaced.Pump checked: pass.Software: 2.24fr.Fcn: 1416.Reason for service: other reason.Results: operational.Per the technician sav contre pulsion in (b)(6): "the error was reported by the user department when used on patients without more information from patient's condition.The pump was replaced by another pump.The hospital did not file complaints".

Manufacturer Narrative

Qn#(b)(4).The pcs assembly (p/n 96-3006-001w, 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 known good autocat2w and performed functional testing.The known good autocat2w with the pcs assembly in question installed failed the functional test.The pump alarmed "helium loss (2)" approximately 15 minutes after initiated pumping.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 detected to be coming from the vent port v1.The vent valve v1 was powered with 12 vdc using external power supply and clicking sound was noted.The external power supply was then switched on/off multiple times with trigger each time.Visual inspection of the pcs assembly internal hardware was performed and no abnormalities were noted.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.See other remarks section.Other remarks: conclusion: the reported complaint of "alarm, helium loss" is confirmed.The reported alarm was replicated during the functional test.The pump alarmed helium loss (2) approximately 15 minutes after initiated pumping.A small leak was detected to be coming from the vent port, which caused the alarm.The cause of vent valve malfunction is undetermined.

Event Description

It was reported via a field service report: (b)(4).Symptom: helium leak.Findings / action taken: pcs assembly replaced.Pump checked: pass.Software: 2.24fr.Fcn: 1416.Reason for service: other reason.Results: operational.Per the technicien (b)(6): "the error was reported by the user department when used on patients without more information from patient's condition.The pump was replaced by another pump.The hospital did not file complaints".

• Brand Name: AUTOCAT2 WAVE FRENCH
• Type of Device: INTRA-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 Key: 5776642
• MDR Text Key: 49034214
• Report Number: 1219856-2016-00151
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500F
• Device Lot Number: 0001052227
• Other Device ID Number: 30801902092183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1