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

Catalog Number IAP-0500

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a field service report: (b)(4) symptom: pump had "unable to refill" alarms while on patient. The pump was switched out quickly with no patient complications. Findings/action taken: pcs assembly sent to and replaced by hospital biomed. Part being returned on (b)(4) fcn level: (b)(4), software level: 2. 24 op
=
on patient and confirmed by biomed.

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 known good autocat2w and performed functional testing. The pump alarmed "unable to refill" approximately 20 minutes after pumping was initiated. The known good autocat2w 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 passed leak testing. All valves were powered with 12 vdc using external power supply and clicking sound was noted; however, the fill valve (v2) was noted to be delay on trigger (clicking sound) approximately one second when power was applied. The external power supply was then switched on/off multiple times and one second delay still occurred. See other remarks section. Other remarks: the suspected fill valve (v2) was removed and replaced with a known good fill valve (v2). The pcs assembly was then reinstalled into a known good autocat2w and the functional test was performed. The pump was ran for over 8 hours and no alarms or errors were occurred. Visual inspection of the pcs assembly internal hardware was performed and dried condensations were noted on and inside the manifold (where drain valve and fill valve connected). Notice: this is an original pcs assembly for this 2009 pump. 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 "alarm, unable to refill" is confirmed. The pump alarmed "unable to refill" approximately twenty minutes after pumping was initiated. The fill valve (v2) was noted to be sticky, which potentially caused the alarm. The cause of the sticky valve is undetermined.

Event Description

It was reported via a field service report: l611357. Symptom: pump had "unable to refill" alarms while on patient. The pump was switched out quickly with no patient complications. Findings/action taken: pcs assembly sent to and replaced by hospital biomed. Part being returned on wws-ar#01722. Fcn level: 1416, software level: 2. 24. Op
=
on patient and confirmed by biomed.

• Brand Name: AUTOCAT2 WAVE
• 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: 5953267
• MDR Text Key: 54826761
• Report Number: 1219856-2016-00199
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0500
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2016
• 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