MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CATHETER,CANNULA AND TUBING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PAL 1923

Device Problem Incorrect Device Or Component Shipped (2962)

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital: in the package was a be-pal 1523 instead of the be-pal 1923.Fortunately they had two 19 fr cannulae in the storage." ref.: #(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).Maquet cardiopulmonary (b)(4) requested the product for investigation but the product was not available.Therefore the investigation was done based on received complaint pictures.Device history record review was performed for the claimed lot numbers and no references were found which are indicating a nonconformance of the product in question.Manufacturing dates of these lot numbers were not conflicted in our production.Moreover,there was no rework record for the claimed lot numbers.In order to clarify if all the products were affected or not,sales records were investigated.The claimed lots also were delivered to (b)(6) and (b)(6).However,there was no complaint related to the same problem.According to the sales records,1 set of be-pal 1923#be-hls cannula 19f al and 1 set of be-pal 1523#be-hls cannula 15 f al were delivered to the same hospital.It could be possible that these claimed products could be mixed in the hospital.Sap database trend search was performed (material 70104.7287,failure code:0604 wrong product packaged)which came to following results:no additional complaint was recorded since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: (b)(4)%,which is below 1%.Due to this information no systemic issue could be determined.Based on the information available at this time, a malfunction of the products cannot be confirmed.Therefore,the complaint is closed as unjustified complaint based on the information above.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs,it will be escalated to quality assurance management for review and determination if further investigation is necessary.

Event Description

(b)(4).

• Brand Name: CATHETER,CANNULA AND TUBING
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6977129
• MDR Text Key: 90872647
• Report Number: 8010762-2017-00344
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2018
• Device Model Number: BE-PAL 1923
• Device Catalogue Number: 701047287
• Device Lot Number: 92179326
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 04/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1