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

Catalog Number IAP-0500I

Device Problem Gas Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via an eqr report symptom: pcs has a leakage and possible helium leakage alarm was displayed during therapy the physician switched iap having more than one available, no problem for the patient. Actions: pcs has been replaced according to high standard service.

Manufacturer Narrative

(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 pump alarmed purge failure (5) immediately 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 mdt-50 leak tester and failed leak testing. Leak was noted to be coming from the drain port. Visual inspection of the pcs assembly internal hardware was performed. Debris and dried blood were found inside the drain valve and manifold block where the drain valve connected to. Notice: the purge failure alarm would occur if system could not pull a negative pressure (drain valve). This is an original pcs assembly, and this 2008 iabp. 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 "possible helium loss alarm" is confirmed based off the leakage from the drain port during leak testing. The pump alarmed purge failure (5) when pumping was initiated. Debris and dried blood were found inside the drain valve and that caused the reported complaint. The root cause of how the blood entered the drain valve is undetermined.

Event Description

It was reported via an eqr report. Symptom: pcs has a leakage and possible helium leakage alarm was displayed during therapy the physician switched iap having more than one available, no problem for the patient. Actions: pcs has been replaced according to high standard service.

• Brand Name: AUTOCAT2 WAVE ITALIAN
• 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: 5837983
• MDR Text Key: 50902253
• Report Number: 1219856-2016-00162
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0500I
• Other Device ID Number: 30801902092190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/24/2016
• 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