MAUDE Adverse Event Report: DATASCOPE CORP. STRINGFELLOW - PEDIATRIC ECC; CARDIOPULMONARY DEVICE

Model Number BEQ-TOP 47800

Device Problem Labeling, missing (2531)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

It was reported that the pack had many points (pigtails) that were not labeled.There was also a segment to be connected which was not.The customer stated that despite these issues, it did not render the circuits unusable.No patient was involved.

Manufacturer Narrative

The device was not returned for evaluation, however the lot files for this device were reviewed.It was determined that during assembly, a note on the drawing requiring a certain label to be added to the "pigtail" components, was missed by the operator and the inspector.In order to address this issue, a capa was initiated and assemblers re-trained.The customer also reported lines that were not connected.A review of the drawings and lot files showed that the lines reported were connected as required during manufacturing.Further communication with the facility revealed that the connection the customer was referring was actually lines 5 and 7.A review of device drawings showed that these lines are not meant to be connected.Therefore the kit was assembled per specification and no further action was required.(b)(4).

• Brand Name: STRINGFELLOW - PEDIATRIC ECC
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3988056
• MDR Text Key: 19925826
• Report Number: 2248146-2014-00094
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: BEQ-TOP 47800
• Device Catalogue Number: 701066583
• Device Lot Number: 17084-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1