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

Catalog Number IAP-0500

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported via a field service report: (b)(4). Symptom: pump had system error #1 alarms and stopped pumping while on patient. Pump switched out quickly. No patient complications. Findings / actions taken: replaced front end board. Software level: (b)(4). Expedited qa review: yes. Confirmed.

Manufacturer Narrative

(b)(4). The front end board (p/n: 77-1010-002 s/n: (b)(4)) was returned for evaluation. Visual inspection of fe board was performed and a burnt capacitor c202 was found. The burnt component c202 was caused a short circuit (-12 volts to ground). No further functional testing can be performed on the front end board due to the damage component c202 (-12 volts circuitry). No further testing can be performed due to a short on the circuitry. 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, system error 1" is confirmed. A burnt component c202 was found on the feb and that caused a short in the circuit. The burnt component was the cause of the reported complaint; however, the root cause of the burnt component c202 is undetermined.

Event Description

It has been reported via a field service report: (b)(4). Symptom: pump had system error #1 alarms and stopped pumping while on patient. Pump switched out quickly. No patient complications. Findings / actions taken: replaced front end board. Software level: 2. 24. Expedited qa review: yes. Confirmed.

• 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: 5844228
• MDR Text Key: 51121998
• Report Number: 1219856-2016-00171
• 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: 07/13/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/03/2016
• 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: 07/22/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/07/2016
• 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